Welcome to the CIBMTR Forms Instruction Manual. The Table of Contents on the left side of the screen is for navigational purposes; if you are on a mobile device you may find the Table on Contents on the top of the page.

General Instructions provides useful general background information for successfully completing forms.

2804/2814: CRID Assignment and Indication provides explanatory text used to generate a CIBMTR Research ID (CRID) and report the indication.

Transplant Essential Data (TED) Manuals provides explanatory text for each question found on the TED forms.

Comprehensive Baseline & Follow-up Forms Manuals provides explanatory text for each question on the Baseline, Follow-up, IDMs, HLA, and Infusion forms.

Comprehensive Disease Specific Manuals provides explanatory text and additional information for disease indications requiring CIBMTR reporting.

Cellular Therapy Manuals provides explanatory text for completing pre-infusion, infusion, and post-infusion forms

Infection & Miscellaneous Manuals provides explanatory text for manuals such as the Hepatitis Serology, VOD / SOS, and Myelofibrosis CMS Study forms.

Appendices provide additional information beyond the scope of the other manuals.

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

Date Manual Section Add/Remove/Modify Description
11/23/2020 2130: SCD Post-Infusion Add Instructions added to question 101 to explain how to report the current disease status when the Hb S ≤ 50% but clinical symptoms are present: If the Hb S is ≤ 50 % but clinical symptoms are present, leave the data field blank, override the FormsNet3 error with “unable to answer,” and explain the Hb S is below ≤ 50 %; however, clinical symptoms are present in the comment section.
11/23/2020 2400: Pre-TED Modify Questions 1 – 5 were updated to explain the CRID Assignment tool should be corrected if an error is identified in these data fields as these data are automatically populated based on what is reported in the CRID Assignment tool: The date of birth is automatically populated based on the value reported in the CRID Assignment Form tool (2804) in FormsNet3. Verify that the date of birth is correct. If an error is noted, correct the CRID Assignment tool Form 2804 and verify that the date of birth has been updated on the Pre-TED Form.
11/23/2020 Appendix J: Reporting Comorbidities Add Clarification added on how to report infection comorbidity: The presence of one or more of the following requiring continuation of therapeutic antimicrobial / antifungal /antiviral treatment after Day 0.
11/23/2020 2400: Pre-TED Add Information added on how to report infection comorbidities in question 97: Infection: Documented infection, fever of unknown origin, or pulmonary nodules requiring continuation of antimicrobial / antifungal / antiviral treatment after day 0.
11/23/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Instructions updated for question 281 on when to use the “not assessed” option for reporting they cytogenetic response: If cytogenetic response was not tested at the last evaluation time of best response to this line of therapy select “Not assessed” and continue with question 283.
11/23/2020 2400: Pre-TED Add Clarification (blue information box) was added to question 119 to clarify MIBG therapy should not be reported as preparative regimen: MIBG Therapy: MIBG therapy given for recipients with neuroblastoma is no longer considered preparative regimen and should not be reported.
11/23/2020 2400: Pre-TED Modify The instructions for question 87 were updated to include when to use the “indeterminant” option for CMV testing: If the laboratory reports the results as “inconclusive” or “equivocal,” select “not done indeterminant
Indicate the test result documented on the laboratory report as either “reactive,” “non-reactive,” “indeterminant,” or “not done.”
11/23/2020 2402: Disease Classification Add Blue information box added to questions 405 – 406 on how to report the Durie-Salmon staging for subsequent infusions: Durie-Salmon staging: If this form is being completed for a subsequent infusion, report the Durie-Salmon staging at the time of the multiple myeloma diagnosis, and not at the time of relapse or progression
11/20/2020 2450: Post-TED Add Clarification added to question 44 to explain topical non-steroidal agents should not be reported: Indicate whether the recipient is still taking systemic non-steroidal immunosuppressive agents (including PUVA) to treat or prevent acute and / or chronic GVHD on the date of contact. Descriptions of many immunosuppressive agents are included below. Only report systemic non-steroidal immunosuppressive agents and not topical non-steroidal immunosuppressive agents such as Restasis or Protopic.
If the recipient did not receive systemic non-steroidal immunosuppressive agents to treat or prevent acute and / or chronic GVHD during the reporting period, report “not applicable.”
Indicate “not applicable” in any of the following scenarios:
  • The recipient has never received systemic non-steroidal immunosuppressive agents (including PUVA) to treat or prevent GVHD.
  • This form is being completed for a subsequent HCT and the recipient has never received systemic non-steroidal immunosuppressive agents (including PUVA) to treat or prevent GVHD since the start of the preparative regimen for the most recent infusion (or since the date of the most recent infusion if no preparative regimen was given).
  • The recipient stopped taking systemic non-steroidal immunosuppressive agents (including PUVA) to treat or prevent GVHD in a previous reporting period and did not restart non-steroidal immunosuppressive agents (including PUVA) during the current reporting period.
  • The recipient has only received topical non-steroidal immunosuppressive agents (i.e., without ever taking systemic non-steroidal immunosuppressive agents were never administered).
11/19/2020 Multiple Myeloma Response Criteria Modify Moved informational blue box about Free Light Chain Ratios to right before section on Stringent Complete Response.
11/18/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Clarified reporting recipient death with new combined follow up rules.
11/17/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added clarification about prophylaxis drugs given to treat neurotoxicity: Indicate “yes” if the recipient received therapy for neurotoxicity and continue with question 130. Indicate “no” if no therapy was given for neurotoxicity and continue with question 132. Report any prophylactic drugs as therapy for neurotoxicity if they were continued after the date of diagnosis.
11/17/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added clarification about prophylaxis drugs given to treat CRS: Indicate “yes” if the recipient received therapy for CRS and continue with question 81. Indicate “no” if no therapy was given for CRS and continue with question 83. Report any prophylactic drugs as therapy for CRS if they were continued after the date of diagnosis.
11/13/2020 4000:Cellular Therapy Essential Data Pre-Infusion Modify Clarified the time period for reporting co-morbid conditions prior to a cellular therapy infusion: Added the following guidance on answering question 37: Additionally, for the purposes of this manual, the term “at the time of patient assessment” is defined as the pre-infusion evaluation period performed with 6 months prior to the start of the lympho-depleting or preparative regimen.
10/23/2020 2116: PCD Post-Infusion Modify Provided clarification and additional examples on how to report next generation flow (NGF) in questions 39-42.
10/23/2020 2016: PCD Pre-Infusion Modify Provided clarification and additional examples on how to report next generation flow (NGF) in questions 225-228.
10/23/2020 4000:Cellular Therapy Essential Data Pre-Infusion Add Added the following guidance on answering question 37:
Question 37 has been “hidden” in FormsNet3 for the current revision of this form. If an NMDP donor ID had been previously entered, this field will not be hidden and can be edited as needed. However, if an NMDP donor ID has not been entered yet, this field will be hidden and skipped until the form is revised and the question is removed from the form.
10/23/2020 2450: Post-TED Add Added the following guidance on answering question 63:
Question 63 has been “hidden” in FormsNet3 for the current revision of this form. If an NMDP donor ID had been previously entered, this field will not be hidden and can be edited as needed. However, if an NMDP donor ID has not been entered yet, this field will be hidden and skipped until the form is revised and the question is removed from the form.
10/23/2020 2400: Pre-TED Add Added the following guidance on answering question 60:
Question 60 has been “hidden” in FormsNet3 for the current revision of this form. If an NMDP donor ID had been previously entered, this field will not be hidden and can be edited as needed. However, if an NMDP donor ID has not been entered yet, this field will be hidden and skipped until the form is revised and the question is removed from the form.
10/23/2020 2400: Pre-TED Add Added the following guidance on answering questions 17 and 18:
Questions 17 and 18 should only be completed for recipients who received an allogeneic transplant. If the recipient received an autologous transplant, these questions should be left blank.
10/23/2020 2118: LYM Post-Infusion Data Modify Modified the guidance prior to question 7 by removing (struck out below) and adding (text in red below) the following information:
If testing was performed by any of these three methods on blood ,or bone marrow , or any other specimen s at the time of best response, report “Yes” and go to question 8. If testing by these methods was not done on blood or bone marrow at the time of best response or it is not known whether testing was performed, report “No” or “Unknown” respectively and go to question 21.
10/23/2020 2018: LYM Pre-Infusion Modify Version 5 of the 2018: Lymphoma Pre-Infusion Data section of the Forms Instruction Manual released. Version 5 corresponds to revision 6 of the Form 2018.
10/23/2020 2100: Post-HCT Follow-Up Modify Version 5 of the 2100: Post-HCT Follow-Up section of the Forms Instructions Manual released. Version 5 corresponds to revision 6 of the Form 2100.
10/23/2020 2402: Disease Classification Modify Version 6 of the 2402: Pre-TED Disease Classification section of the Forms Instructions Manual released. Version 6 corresponds to revision 6 of the Form 2402.
10/23/2020 2030: SCD Pre-Infusion Add Added the following guidance on answering questions 17 and 18: Questions 17 and 18 are currently disabled and should not be completed on this form. These data are already collected on the Baseline (2000) Form and do not need to be reported again.
10/23/2020 2128: Aplastic Anemia Post-HCT Modify Version 3 of the 2128: Aplastic Anemia Post-HCT Data section of the Forms Instructions Manual released. Version 3 corresponds to revision 3 of the Form 2128.
10/23/2020 2028: Aplastic Anemia Pre-HCT Modify Version 2 of the 2028: Aplastic Anemia Pre-HCT Data section of the Forms Instructions Manual released. Version 2 corresponds to revision 3 of the Form 2028.
10/23/2020 2000: Recipient Baseline Modify Version 4 of the 2000: Recipient Baseline section of the Forms Instruction Manual released. Version 4 corresponds to revision 6 of the Form 2000.
10/15/2020 4100: Cellular Therapy Essential Data Follow-Up Add Clarification added on the intent of this section for cell therapy versus the HCT.
10/14/2020 Appendix J: Reporting Comorbidities Add Clarification added on how to report a pulmonary comorbidity if both a “control” FEV1 and “post-dilator” FEV1 is available.
10/14/2020 2400: Pre-TED Add Clarification added to question 96 on how to report a pulmonary comorbidity when both a “control” FEV1 and “post-dilator” FEV1 is available.
10/7/2020 4100: Cellular Therapy Essential Data Follow-Up Remove Removed the note box above question 2, these questions are enabled for all cases: For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100/2450 and F4100. To reduce the reporting burden, duplicated questions on the Cellular Therapy forms are disabled. This includes contact date and survival reported on F4100.
10/7/2020 2039: HLH Pre-HCT Add Clarification added to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2039 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2039. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2039 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2019: WM Pre-HCT Add Clarification added to question 76 to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2019 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2019. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2019 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2016: PCD Pre-Infusion Modify Clarification updated to provide instructions on how to report lines of therapy for subsequent infusions to be consistent: If this form is being completed for a second or subsequent transplant for relapse or progression of the same disease, report all therapy given for relapse or progression of disease. Do not report maintenance therapy given after the prior transplant, as this will be captured on the post-transplant disease inserts associated with the prior transplant. Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2016 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2016. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2016 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2402: Disease Classification Add Clarification added on how to answer the number of induction cycles for questions 92 and 160: Number of Induction Cycles The intent of this question is to capture the number of induction cycles required to achieve the first CR (including CRi) in the recipient’s disease history, regardless of if there have been prior relapses or infusions
10/7/2020 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion Add Clarification added to question 55 to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2057 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2057. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2057 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2015: JMML Pre-HCT Add Clarification added to question 49 to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2015 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2015. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2015 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2014: MDS Pre-Infusion Add Clarification added to question 82 to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2014 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2014. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2014 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2013: CLL Pre-Infusion Add Clarification added to question 74 to explain how to report lines of therapy for a subsequent infusion: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2013 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2013. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2013 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2012: CML Pre-Infusion Data Add Clarification added to question to 84 to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2012 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2012. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2012 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2011: ALL Pre-Infusion Add Clarification added to question 20 to explain how to report lines of therapy for a subsequent infusion: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2011 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2011. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2011 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/7/2020 2010: AML Pre-Infusion Add Instructions added above question 32 to provide clarification how to report lines of therapy for a subsequent infusion: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and 2010 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2010. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2010 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
10/6/2020 2018: LYM Pre-Infusion Add The instructions on how to report lines of therapy for subsequent infusions above question 166 was made into a “red warning box.”
10/6/2020 Appendix H: MDS/MPN Subtypes Modify Updated the criteria of the different variations of atypical CML to only “atypical CML, BCR-ABL1-negative” as the variations were all of the same thing: Atypical chronic myeloid leukemia, Ph – / BCR – (CML, NOS) BCR-ABL1-negative
  • Peripheral blood leukocytosis, ≥ 13 × 109/L
  • Blasts < 20% in peripheral blood and bone marrow
  • Dysgranulopoiesis is present in the bone marrow
  • Myelodysplastic and myeloproliferative features
  • No evidence of PDGFRA, PDGFRB, or FGFR1 rearrangement
  • No abnormalities of PDGFRA or PDGFRB
  • No Ph+ or BCR-ABL fusion
    Atypical chronic myeloid leukemia Ph – / BCR unknown (CML, NOS)
  • Peripheral blood leukocytosis, ≥ 13 × 109/L
  • Blasts < 20% in peripheral blood and bone marrow
  • Dysgranulopoiesis is present in the bone marrow
  • Myelodysplastic and myeloproliferative features
  • No abnormalities of PDGFRA or PDGFRB
  • No Ph+ and BCR-ABL fusion unknown
    Atypical chronic myeloid leukemia Ph unknown / BCR – (CML, NOS)
  • Peripheral blood leukocytosis, ≥ 13 × 109/L
  • Blasts < 20% in peripheral blood and bone marrow
  • Dysgranulopoiesis is present in the bone marrow
  • Myelodysplastic and myeloproliferative features
  • No abnormalities of PDGFRA or PDGFRB
  • Ph chromosome unknown and no BCR-ABL fusion
    Atypical chronic myeloid leukemia Ph unknown / BCR unknown (CML, NOS)
  • Peripheral blood leukocytosis, ≥ 13 × 109/L
  • Blasts < 20% in peripheral blood and bone marrow
  • Dysgranulopoiesis is present in the bone marrow
  • Myelodysplastic and myeloproliferative features
  • No abnormalities of PDGFRA or PDGFRB
  • Ph chromosome and BCR-ABL fusion unknown
10/6/2020 2018: LYM Pre-Infusion Add Clarification added on some of the option values for question 76-77: Check each site with known lymphomatous involvement. Clarification on some of the available option values found below
  • Adrenal: The adrenals gland are small glands that sit on the top of each kidney and product hormones including sex hormones and cortisol. Select this option if there was lymphomatous involvement of or derived from the adrenal glands or their secretions.
  • Cerebrospinal fluid (CSF): A clear, colorless body fluid found in the brain and spinal cord that is produced by specialized ependymal cells.
  • Epidural space: The epidural space is an anatomic space that is the outermost part of the spinal canal. The epidural space contains lymphatics, spinal nerve roots, loose fatty tissue, small arteries, and a network of internal vertebral venous plexuses.
  • Gastrointestinal (GI) tract: Any of the organs that food and liquids travel through when they are swallowed, digested, absorbed, and leave the body as feces. These organs include the mouth, pharynx, esophagus, stomach, small intestine, large intestine, rectum, and anus.
  • Pericardium: Of or pertaining to the membrane enclosing the heart that consists of an outer fibrous later and an inner double layer of serous membrane.
  • Pleura: The delicate serous membrane that lines each half of the thorax of mammals and is folded back over the surface of the lung of the same side. The function of the pleura is to allow optimal expansion and contraction of the lungs during breathing.
  • Skin: Of or pertaining to the outer or surrounding layer of the skin (epidermis).
  • Spleen: Of or pertaining to the abdominal organ involved in the product and removal of blood cells.
    If an involved site was documented but is not listed as an option for question 76, check “Other site” and report all other sites of lymphomatous involvement in question 77.
10/5/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Add Clarification added on when to report “yes” and “no” for question 203: Report “yes” for question 203 and go to question 276 in any of the following scenarios:
  • Disease was detected by any method in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 105-181) and no therapy was given to treat disease between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 105-181) for the form and the date of contact for this reporting period the most recent disease assessments in the reporting period have already been reported in questions 105-202 (Disease Detection Since the Date of Last Report)
  • Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 105-181), therapy was administered, but no assessments were performed after the initiation of therapy if assessments were reported in questions 105-202 (Disease Detection Since the Date of Last Report) and no therapy was given to treat disease between the date(s) of the reported assessments and the date of contact for this reporting period
    Report “no” for question 203 and report the most recent disease assessments in the reporting period in questions 204 – 275 in any of the following scenarios
  • Disease was not detected by any method of assessment during the reporting period
  • Disease was detected (color-red) in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 105-181), therapy was administered, and additional assessment(s) were performed after therapy by at least one method of assessment during the reporting period (reported in questions 105-202), but the most recent assessments have not yet been reported on the form
10/5/2020 MDS Post-HCT Add Clarification added on when to report “yes” and “no” for question 172: Report “Yes” for question 172 and go to question 233 in any of the following scenarios:
  • Disease was detected by any method in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 88 – 151) and no therapy was given to treat disease between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 88 – 151) for the form and the date of contact for this reporting period the most recent disease assessments in the reporting period have already been reported in questions 88-151 (Disease Detection Since the Date of Last Report)
  • Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 88 – 151), therapy was administered, but no assessments were performed after the initiation of therapy if assessments were reported in questions 88-151 (Disease Detection Since the Date of Last Report) and no therapy was given to treat disease between the date(s) of the reported assessments and the date of contact for this reporting period
    Report “no” for question 172 and report the most recent disease assessments in the reporting period in questions 173 – 232 in any of the following scenarios:
  • Disease was not detected by any method of assessment during the reporting period
  • Disease was detected in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 88 – 151), therapy was administered, and additional assessment(s) were performed after therapy by at least one method of assessment during the reporting period (reported in questions 88-151), but the most recent assessments have not yet been reported on the form
    In addition, the graphic was added.
10/5/20 ALL Post-Infusion Add Clarification added on when to report “yes” and “no” to question 95: Report “Yes” for question 95 and go to question 129 in any of the following scenarios:
  • Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 48-80) and no therapy was given to treat diseases between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 48-80) for the form and the date of contact for this reporting period
  • Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 48-80), therapy was administered, but no assessments were performed after the initiation of therapy if the most recent disease assessments have already been reported in questions 48-80. Also, report “Yes” for question 95 and go to question 129 if assessments were reported in questions 48-80 and no therapy was given to treat disease between the date(s) of the reported assessments and the date of the contact for this reporting period
    Report “No” for the question 95 and %(color-red)report the most recent disease assessments in the reporting period in questions 96 – 128 in any of the following scenarios
  • Disease was not detected by any method of assessment during the reporting period
  • Disease was detected in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 48 – 80), therapy was administered, and additional assessment(s) were performed after therapy by at least one method of assessment during the reporting period (reported in questions 48-80), but the most recent assessments have not yet been reported on the form
    In addition, the graphic and example E were added.
10/5/2020 2110: AML Post-Infusion Add Further clarification added on when to answer “yes” and “no” for Q104: Report “Yes” for question 104 and go to question 144 in any of the following scenarios:
  • Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last report, questions 51 – 89) and no therapy was given to treat disease between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 51-58) for the form and the date of contact for this reporting period
  • Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 51 – 89), therapy was administered, but no assessments were performed after the initiation of therapy if the most recent disease assessments have already been reported in questions 51-89. Also, report “Yes” for question 104 and go to question 144 if assessments were reported in questions 51-89 and no therapy was given to treat disease between the date(s) of the reported assessments and the date of the contact for this reporting period
    Report “No” for question 104 and report the most recent disease assessments in the reporting period in questions in 105 – 143 in any of the following scenarios:
  • Disease was not detected by any method of assessment during the reporting period
  • Disease was detected in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 51 – 89), therapy was administered, and additional assessment(s) were performed after therapy by at least one method of assessment during the reporting period (reported in questions 51-89), but the most recent assessments have not yet been reported on the form
    In addition, the graphic and example E were added.
10/2/2020 POEMS Response Criteria Add POEMS Response Criteria section of the Forms Instructions Manual released.
10/1/2020 2116: PCD Post-Infusion Add Instructions added on when to use the “unknown” and “not applicable” options for question 190: Indicate if the recipient received maintenance therapy after treatment for relapse / progression since the date of the last report. If “yes,” continue with question 191. If “no,” continue with question 211. If it is not known or not possible to determine if the recipient was placed on subsequent maintenance therapy after treatment for relapse / progression, then select “Unknown” and proceed to question 211. This option should be used sparingly and only in cases when it is truly unknown as to whether maintenance therapy was given within the reporting period after treatment for relapse / progression. Indicate “Not Applicable” if the recipient did not receive treatment for relapse / progression. Please see the example below: Example: A recipient was in CR and was receiving maintenance Revlimid. Due to health issues, the maintenance therapy was briefly discontinued; however, the recipient’s IgG reappeared during this time. The patient was not treated for relapse and eventually continued on with the Revlimid maintenance. In this case, question 190 would be answered as “Not Applicable” because he was not treated for relapse but instead continued on with his maintenance therapy.
10/1/2020 AML Response Criteria Remove The response criteria for CR and CRi were updated to consistent with 2017 ELN AML Response Criteria. CR and CRi no longer requires the criteria is maintained for at leas four weeks and “normal maturation of all cellular components in the bone marrow” is not required:
Complete Remission
Hematologic complete remission is defined as meeting all of the following response criteria for at least four weeks:
  • < 5% blasts in the bone marrow
  • No blasts with Auer rods
  • Normal maturation of all cellular components in the bone marrow
  • No extramedullary disease (e.g., CNS, soft tissue disease)
  • Neutrophils ≥ 1,000/µL
  • Platelets ≥ 100,000/µL
  • Transfusion independent
    Complete Remission with Incomplete Hematologic Recovery (CRi)
    Hematologic complete remission with incomplete hematologic recovery is defined as meeting all of the following response criteria for at least four weeks:
  • < 5% blasts in the bone marrow
  • No blasts with Auer rods
  • Normal maturation of all cellular components in the bone marrow
  • No extramedullary disease (e.g., CNS, soft tissue disease)
  • Transfusion independence (Please note, if the physician documents transfusion dependence related to treatment and not the patient’s underlying AML, CRi can be reported)
10/1/2020 AML Response Criteria Add Clarification was added to the For recipients with MDS / MPN / MF that transformed to AML blue information box that this instruction also applies to recipients with AML with MDS related changes along with examples 1 and 2: Historically, for recipients who had residual MDS / MPN / MF following treatment for AML, the AML disease status was reported as either PIF or relapse (i.e., the recipient cannot be in an AML CR if there is evidence of MDS / MPN / MF at the time of assessment). However, this instruction was removed in May 2020 and an AML CR may be reported if there is residual MDS / MPN / MF as long as there are < 5% blasts in the bone marrow as well as 0% blasts in the peripheral blood. This instruction also applies to recipients whose primary disease for transplant is “AML with MDS related changes”
Example 1: A recipient who transformed from MDS to AML received AML induction therapy. A bone marrow biopsy was performed post-induction and showed remission; however, there was still evidence of dysplasia present. The recipient did not receive additional therapy and went to transplant. In this scenario, the pre-transplant disease status may be reported as “CR.”
Example 2: A recipient who transformed from primary myelofibrosis to AML achieved remission following induction therapy and went to transplant. During the Day 100 reporting period, a bone marrow biopsy was performed, and myelofibrosis was present. In this case, the post-transplant disease status may still be reported as “CR.”
9/30/2020 2450: Post-TED Modify The table for time windows for reporting the contact date in Q1 was updated to clarify the 1Y date of contact date should be reported as + 60 days (Day 365 – 425).
9/30/2020 2100: Post-HCT Follow-Up Modify The table for time windows for reporting the contact date in Q1 was updated to clarify the 1Y date of contact date should be reported as + 60 days (Day 365 – 425).
9/30/2020 4100: Cellular Therapy Essential Data Follow-Up Add The blue information box was added to question 2 to explain how to report the contact date for the D100 reporting period: If this form is being completed for the 1-year reporting period, ensure the reported contact date is ≥ Day 365.
9/25/2020 Multiple Myeloma Response Criteria Add Additional criteria for Light Chain Only Myeloma added to PR:
Light Chain Only Myeloma (e.g., kappa or lambda only)
  • ≥ 50% reduction in serum M-protein
  • Reduction in 24-hour urinary M-protein by ≥ 90 % or to < 200 mg/24 hours
  • ≥ 50% decrease in the difference between the involved and uninvolved free light chain levels (applicable to Light Chain Only Myeloma)
9/24/2020 Multiple Myeloma Response Criteria Modify The Partial Response criteria for Measurable Myeloma was updated. Both criteria are not required to be met, only one more is needed: Both One or more of the following criteria must be met:
In addition, the following sentence was removed from the Partial Response criteria: Transplant centers may not perform urine studies on a regular basis. In that case, only the ≥ 50 % reduction in the serum M-protein is required for Heavy Chain and Light Chain Only Myeloma
9/24/2020 Multiple Myeloma Response Criteria Add Additional criteria for Light Chain Only Myeloma added to VGPR and Progressive Disease:
VGPR
  • Serum and urine M-protein detectable by immunofixation but not on electrophoresis
  • ≥ 90 reduction in serum M-protein and urine M-protein level < 100 mg/24 hours
  • ≥ 90% decrease in the difference between involved and uninvolved free light chain levels (applicable to Light Chain Only Myeloma)
    Progressive Disease
  • Increase of ≥ 25% from the lowest response value achieved in one or more of the following:
    • Urine M-protein with an absolute increase ≥ 200 mg/24 hours
    • The difference between involved and uninvolved free light chain levels with an absolute increase > 10 mg/dL (applicable to Light Chain Only Myeloma)
    • Bone marrow plasma cell percentage with an absolute increase of at least 10% plasma cells
9/23/2020 4000: Cellular Therapy Essential Data Pre-Infusion Modify Corrected the formatting in the list of co-morbid conditions under question 115.
9/18/2020 4000: Cellular Therapy Essential Data Pre-Infusion Modify Updated the instruction for reporting the new FDA approved product “Tecartus”: Please report the new FDA approved product ‘Tecartus (brexucabtagene autoleucel)’ as ‘Yescarta’. The products will be distinguished by the lymphoma histology. The new product name will be added to the option list in the next revision to be released in January 2021.
9/10/2020 2046: Fungal Infection Pre-Infusion Data Add Red warning box added to question 31 to explain the “unknown” option should never be used: The “Unknown” option should never be used to report the status of the infection. The options on the form will be revised with the next revision of this form.
9/10/2020 2400: Pre-TED Add An example added to question 80 to explain how to report the number of products infused when there is a change in mobilization: Example 2 (change in mobilization): A G-CSF stimulated donor had a PBSC collection, but the cell count was poor. Plerixafor (Mozobil) was added as part of the mobilization and the donor was re-collected the following day. As the change in mobilization occurred during the same mobilization cycle, these collections are considered a single product.
9/9/2020 4000: Cellular Therapy Essential Data Pre-Infusion Add Clarification added on how to report ADD and ADHD as comorbidities to question 115: Psychiatric disturbance – The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks.
9/9/2020 Appendix J: Reporting Comorbidities Add Clarification added on how to report ADD and ADHD: Psychiatric disturbance – Any psychiatric illness requiring treatment within four weeks prior to the pre-transplant work-up period. Examples include depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), schizophrenia, or bipolar disorder.
9/9/2020 2400: Pre-TED Add Clarification added on how to report ADD and ADHD as comorbidities in question 97: Psychiatric disturbance – The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks.
9/9/2020 2014: MDS Pre-Infusion Add Clarification added on how to report relapse / progression following the line of therapy for recipients who transform to AML in question 155: Refer to the MDS Response Criteria section when determining the recipient’s disease status. Indicate if the disease relapsed from CR or progressed from hematologic improvement. If the disease relapsed, progressed, or transformed to AML (see red box below) answer “Yes” and go to question 156. If “No,” go to question 157.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Provided clarification (red text) on how to report multiple values: If there is the same maximum lab value across multiple days, report the first date.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added below question 77 to clarify how to report HLH/MAS: HLH/MAS is recognized as being part of the CRS spectrum. If the patient has developed HLH/MAS, please report “yes” for CRS and report any treatment given for HLH/MAS in question 80.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added below question 80 to clarify how to report HLH/MAS: HLH/MAS is recognized as being part of the CRS spectrum. If the patient has developed HLH/MAS, please report “yes” for CRS and report any treatment given for HLH/MAS in question 80.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added below question 145 to clarify how to report HLH/MAS: HLH/MAS is recognized as being part of the CRS spectrum, however, the option does not yet exist to report it under CRS. If the patient has developed HLH/MAS, please report it here as an “other toxicity”.
8/26/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added above question 180 to clarify how to report COVID-19 infection when diagnosed after the start of the lymphodepleting therapy: Diagnosis of COVID-19 after the start of the lymphodepleting therapy: Any COVID-19 infections diagnosed after the start of the lymphodepleting therapy should be reported in questions 180 – 184 on the Cellular Therapy Essential Data Follow-Up (4100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated.
8/26/2020 2100: Post-HCT Follow-Up Add Blue information box added above question 428 to explain how to report COVID-19 infections when diagnosed after the start of the preparative regimen: Diagnosis of COVID-19 after the start of the preparative regimen: Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in questions 428 – 236 on the Post-HCT Follow-Up (2100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated.
8/26/2020 2450: Post-TED Add Blue information box added above question 50 to explain how to report COVID-19 infections when diagnosed after the start of the preparative regimen: Diagnosis of COVID-19 after the start of the preparative regimen: Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in questions 50 – 51 on the Post-TED (2450) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated.
8/26/2020 4000: Cellular Therapy Essential Data Pre-Infusion Add Blue instruction box added above question 111 to clarify how to report the COVD-19 infections when diagnosed after the start of the lymphodepleting therapy: Diagnosis of COVD-19 after the start of the lymphodepleting therapy: Questions 111 – 113 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the lymphodepleting therapy / infusion. If a COVID-19 infection is diagnosed after the start of the lymphodepleting therapy, report the COVID-19 diagnosis on the post-infusion follow-up form (2450, 2100, and / or 4100).
8/26/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added above question 180 to clarify how to report COVID-19 infection when diagnosed after the start of the lymphodepleting therapy: Diagnosis of COVID-19 after the start of the lymphodepleting therapy: Any COVID-19 infections diagnosed after the start of the lymphodepleting therapy should be reported in questions 180 – 184 on the Cellular Therapy Essential Data Follow-Up (4100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated.
8/26/2020 2400: Pre-TED Add Blue information box added above question 88 to explain how to report COVID-19 infections when diagnosed after the start of the preparative regimen: Diagnosis of COVD-19 after the start of the preparative regimen: Questions 88 – 90 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the preparative regimen / infusion. If a COVID-19 infection is diagnosed after the start of the preparative regimen, report the COVID-19 diagnosis on the post-infusion follow-up form (2450, 2100, and / or 4100).
8/25/2020 2146: Fungal Infection Post-Infusion Data Add Clarification added on when to report fungal prophylaxis as treatment in question 43: Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of diagnosis (refer to question two) through the date of contact for the reporting period (refer to the date of contact reported on the corresponding follow-up form). If the recipient did not receive any antifungal therapy during this time frame, report “No” and go to question 49. If the dose of fungal prophylaxis was increased to a therapeutic dose during the specified time window (seven days prior to the diagnosis date through the date of contact), report “Yes.”
8/25/2020 2046: Fungal Infection Pre-Infusion Data Add Instruction added on when to use the “Unknown” option for the diagnostic methods of assessment in questions 3-25: Methods of Assessment -
A fungal infection may be identified by multiple assessments near the time of diagnosis. A description of each method of assessment is provided below. Report “Yes” for all assessments which were positive for signs of the fungal infection being reported on this form. Report “no” for assessments which were never performed or were never considered to be positive for the fungal infection being reported on this form. If the significance of the test result is not clear, obtain documentation from the recipient’s physician confirming whether the assessment was considered positive. Report “No” for assessments with results which are determined to be equivocal or indeterminate. The “Unknown” option should be used sparingly and only when there is no information on how the fungal infection was diagnosed.
8/25/2020 2046: Fungal Infection Pre-Infusion Data Add Clarification added to question 26 on when to report fungal prophylaxis as treatment: Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of diagnosis (refer to question two) through the day of infusion (Day 0 for HCT or cellular therapy). If the recipient did not receive any antifungal therapy during this time frame, report “No” and go to question 31. If the dose of fungal prophylaxis was increased to a therapeutic dose during the specified time window (seven days prior to the diagnosis date through the day of infusion), report “Yes.”
8/24/2020 2118: LYM Post-Infusion Data Add Blue instruction box added above questions 65 and 72 on how to report intrathecal and intraocular therapies when multiple are given in a single line: If a recipient receives multiple intrathecal / intraocular therapies as part of a single line of therapy, report each intrathecal / intraocular therapy as a separate line.
8/24/2020 2018: LYM Pre-Infusion Add Blue instruction box added above questions 180 and 188 to clarify if multiple intrathecal / intraocular therapies are given as part of a line of therapy to report each as a separate line: If a recipient receives multiple intrathecal / intraocular therapies as part of a single line of therapy, report each intrathecal / intraocular therapy as a separate line.
8/24/2020 2011: ALL Pre-Infusion Add Clarification added to question 52 on how to report the MRD status was the recipient was MRD negative prior to therapy completion but not retested: If any MRD testing was performed following the line of therapy being reported, answer question 58 based on the results of the testing performed within 30 days after the date therapy was stopped and prior to any new therapy being initiated. If any MRD testing during this timeframe was positive for markers of ALL, report “No” for question 58. If all MRD testing during this time frame was negative for markers of ALL, report “Yes” for question 58. If the recipient was MRD negative prior to therapy completion and not retested after therapy ended, report “Yes” for question 52.
8/24/2020 2010: AML Pre-Infusion Add Instructions added to question 58 on how to report the MRD status when the recipient was negative for MRD prior to therapy completion but MRD testing was not repeated after therapy ended: If any MRD testing was performed following the line of therapy being reported, answer question 58 based on the results of the testing performed within 30 days after the date therapy was stopped and prior to any new therapy being initiated. If any MRD testing during this timeframe was positive for markers of AML, report “No” for question 58. If all MRD testing during this time frame was negative for markers of AML, report “Yes” for question 58. If the recipient was MRD negative prior to therapy completion and not retested after therapy ended, report “Yes” for question 58. If no MRD testing was performed during this timeframe, leave question 58 blank and override the error in FormsNetSM using the code “Unknown.”
8/24/2020 2010: AML Pre-Infusion Add Clarification added on how to report sites of relapse when detected in the bone marrow and / or peripheral blood for questions 61 – 68: Report all known sites of active disease at the time of relapse in questions 61-68. This includes any sites identified between the date of relapse reported in question 60 and the time treatment for relapse is initiated. If “Yes” has been reported for “Other site” in question 67, use question 68 to specify all sites of active disease not already reported in questions 61-66. If relapse was detected in the bone marrow and / or peripheral blood, report “Yes” for question 67 and specify these sites in question 68.
8/24/2020 2010: AML Pre-Infusion Add Instructions added to use the general rules of rounding when reporting the months of therapy in questions 43 – 45: Azacytidine, decitabine, and sorafenib may be given daily rather than in cycles. In order to capture the duration for which these medications are given, centers are asked to report the number of months these drugs were given whenever they have been reported in question 42. If therapy is given greater than a whole month, use the general rules of rounding (i.e., A recipient receives sorafenib twice a day for 13 weeks – specify the months of therapy as “3”).
8/24/2020 2011: ALL Pre-Infusion Add Instructions provided on how to report bone marrow and peripheral blood as sites of relapse in questions 55 – 63: Report all known sites of active disease at the time of relapse in questions 55-63. This includes any sites identified between the date of relapse reported in question 54 and the time treatment for relapse is initiated. If “Yes” has been reported for “Other site” in question 62, use question 63 to specify all sites of active disease not already reported in questions 55-61. If relapse was detected via bone marrow and / or peripheral blood, report “Yes” for question 62 and specify these sites in question 63.
8/24/2020 2011: ALL Pre-Infusion Add Clarification added to question 73 on when to use the “unknown” option: Indicate whether flow cytometry (immunophenotyping) was performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. If “Yes,” go to question 74. If “No” or “Unknown,” go to question 82. Report “No” and continue with question 82 if flow cytometry was not performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. Report “Unknown” and continue with question 82 if there is no information to determine if flow cytometry was performed or not performed at the last evaluation prior to the start of the preparative regimen / infusion.
8/24/2020 2010: AML Pre-Infusion Add Clarification added to question 79 on when to use the “unknown” option: Indicate whether flow cytometry (immunophenotyping) was performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. If “Yes,” go to question 80. If “No” or “Unknown,” go to question 88. Report “No” and continue with question 88 if flow cytometry was not performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. Report “Unknown” and continue with question 88 if there is no information to determine if flow cytometry was performed or not performed at the last evaluation prior to the start of the preparative regimen / infusion.
8/21/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Modify Updated the following note box (above Q159) to clarify the intent of Q159-170:
The following questions (160 159 -170) apply only to non-NMDP allogeneic related donors. If the stem cell product was from an autologous donor, non-NMDP unrelated donor, NMDP donor, or was a cord blood unit, then continue with the signature lines at the end of the form.
8/20/2020 2450: Post-TED Modify The instructions on how to report disease assessments at the time of best response when a recipient never achieves a CR, progresses, and starts progression therapy were updated in question 84: If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period. If the recipient never achieved a CR and has started treatment fore relapsed. progressive , or persistent disease (excluding treatment for minimal residual disease), report the most recent latest assessment prior to the initiation of therapy progression. Review example E below.
In addition, example E was added: E. A recipient receives a transplant on 1/1/2015 for NHL in stable disease. During the 100 Day reporting period, a PET / CT was performed on Day 60, confirming stable disease but then on Day 95, another PET / CT was performed and showed progression. As a result, therapy for progression began on Day 100. The best response to HCT for the Day 100 reporting period would be reported as “Not in complete remission – disease detected” and report “Yes,” radiologic assessments were performed with the Day 60 PET / CT as this is the most recent scan prior to progression.
8/19/2020 2402: Disease Classification Add Blue information box added above question 412 to indicate questions 412 – 441 refer to the labs and assessments performed at the diagnosis of the primary disease for transplant.
8/19/2020 2450: Post-TED Add Examples 1, 2, and 3 added to question 43 to explain when to use “Yes,” No.” and “Not applicable.”
8/19/2020 2100: Post-HCT Follow-Up Add Examples 1, 2, and 3 were added to question 401 to explain when to use “Yes,” “No,” and “No applicable.”
8/19/2020 MDS Response Criteria Modify Clarification added on how to report the CR and HI achievement date – the first date in which the disease status was achieved should be reported, not the date in which the disease status was sustained. See the following for an example: When reporting the CR achievement date, report the first date when CR was achieved (not the four week date in which CR was maintained).
8/19/2020 MPN Response Criteria Modify Updated the response criteria for CR, Myelofibrosis CR, Partial Response, and Clinical Improvement by adding in clarification to report the first date in which the disease status was achieved, not the 12 week date in the disease status was maintained. See the following example for CR: When reporting the CR achievement date, report the first date when CR was achieved (not the 12 week date in which CR was maintained).
8/19/2020 2014: MDS Pre-Infusion Modify The instruction for which question should be answered next if HI-N or HI-P was updated as the previous instructions were incorrect: If the cell lines examined to determine hematologic improvement only included “Hematologic Improvement, Platelets (HI-P)” and / or “Hematologic Improvement, Neutrophils (HI-N)” continue with question 155 154.
8/19/2020 2402: Disease Classification Modify Updated the Common Disease Transformation table for CLL to NHL, found in question 1-2. When a recipient transforms from CLL to NHL, multiple sections of the Disease Classification (2402) Form are not required to be completed.
8/18/2020 2400: Pre-TED Add Provided clarification for question 121 on how to report radiation boosts: Additionally, “radiation boosts,” often given to smaller sites that may have residual malignant cells or to areas that were shielded (i.e., chest wall or lung), should not be reported in this section. Report irradiation boosts administered on the applicable Recipient Baseline Data (2000) Form.
8/18/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Red warning box added above questions 262-23, explaining the question text is currently incorrect and will be revised with next revision of the form: The question text for questions 262 – 263 are incorrect. Currently, the question reads “Was disease detected via bone marrow examination;” however, the question should say “Was disease assessed via bone marrow examination.” This question will be updated with the next revision of this form.
8/18/2020 MDS Post-HCT Add Red warning box added above questions 219-220 to clarify the instruction text is currently incorrect but will be updated with the next revision of the form: The question text for questions 219 – 220 are incorrect. Currently, the question reads “Was disease detected via bone marrow examination;” however, the question should say “Was disease assessed via bone marrow examination.” This question will be updated with the next revision of this form.
8/18/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Blue information box added above questions 19, 117, and 214 to provide instructions on how to report CALR testing: If CALR testing was performed but the lab report does not specify the type, select “not done” for questions 25 and 26 and specify the results as either “positive” or “negative” for question 27.
8/18/2020 2402: Disease Classification Add Blue information box added above Q279 to provide instructions on how to report CALR testing: If CALR testing was performed but the lab report does not specify the type, select “not done” for questions 284 and 285 and specify the results as either “positive” or “negative” for question 286.
8/11/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following blue information box (in red) above question 4:
For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100/2450 and F4100. To reduce the reporting burden, duplicated questions on the Cell Therapy forms are disabled. This includes a subsequent cellular therapy infusion reported on F4100.
8/11/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following blue information box (in red) above question 2:
For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100/2450 and F4100. To reduce the reporting burden, duplicated questions on the Cellular Therapy forms are disabled. This includes contact date and survival reported on F4100.
8/10/2020 Appendix O: Cellular Therapy Critical Fields Add Appendix O: Cellular Therapy Critical Fields released.
8/4/2020 Amyloidosis Response Criteria Remove Removed the following (struck out below) criteria from the Hematologic Complete Response Criteria:
Requires all of the following:
  • Serum and urine negative for monoclonal proteins by immunofixation
  • Normal free light chain ratio
  • Plasma cells in marrow < 5%
8/3/2020 4000: Cellular Therapy Essential Data Pre-Infusion Modify Updated the instruction for reporting NCT ID: “All clinical trials are required to be registered on the clinicaltrials.gov website and will have an associated identification number. Report the number in question 12, do not include the letters “NCT” that precede the digits.”
7/31/2020 2400: Pre-TED Add Provided clarification to question 51 on what to select if the infusion is gene therapy: If the infusion is a gene therapy, select “yes.”
7/31/2020 2814: Indication for CRID Assignment Add Provided instructions in question 1 on which option to select if the infusion is gene therapy: If the infusion type is gene therapy, select “Hematopoietic cellular transplant.”
7/31/2020 2814: Indication for CRID Assignment Add Added the blue information box above question 1 notifying that if the infusion is gene therapy, the recipient will be placed on the HCT CRF track: Gene Therapy: If the infusion type is a gene therapy, the recipient will be placed on the HCT CRF track.
7/29/2020 4000: Cellular Therapy Essential Data Pre-Infusion Add Added the following note box under question 49: Please report the new FDA approved product ‘Tecartus (brexucabtagene autoleucel)’ under “other product” and specify the name as ‘Tecartus’ in question 50 until the name can be added to the option list.
7/24/2020 2543: Mylotarg™ Supplemental Data Collection Add Version 1 of the 2543: Mylotarg™ Supplemental Data Collection section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2543.
7/24/2020 2030: SCD Pre-Infusion Add Version 1 of the 2030: Sickle Cell Disease (SCD) Pre-Infusion Data section of the Forms Instruction Manual released. Version 1 corresponds to revision 3 of the Form 2030.
7/24/2020 2130: SCD Post-Infusion Add Version 1 of the 2130: Sickle Cell Disease (SCD) Post-Infusion Data section of the Forms Instruction Manual released. Version 1 corresponds to revision 3 of the Form 2130.
7/24/2020 2057: MPN Pre-Infusion Add Added the following warning box (in red below) above question 250:
Total Serum Ferritin
Questions 250-252 are disabled and cannot be answered at this time. The total serum ferritin is already captured in the “Comorbid Conditions” section of the Pre-TED (2400) Form (questions 103-106).
7/24/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Modified the date of contact instructions to reflect the new hard stop functionality associated with the Summer 2020 Form Release.
7/24/2020 2018: LYM Pre-Infusion Modify Modified the instructions for completing this form for a subsequent infusion.
7/17/2020 2100: Post-HCT Follow-Up Add Provided guidelines on how to report the maximum grade of chronic GVHD to question 302 to be consistent with the Post-TED (2450): Mild: Signs and symptoms of chronic GVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy (e.g. corticosteroids and/or cyclosporine or FK 506); Moderate: Signs and symptoms of chronic GVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy (e.g. corticosteroids and/or cyclosporine or FK 506); Severe: Signs and symptoms of chronic GVHD limit function substantially despite appropriate therapy or are progressive through second line therapy.
7/10/2020 Multiple Myeloma Response Criteria Modify Update the response criteria for PR to be consistent with the IWG criteria and provided clarification when only one of the criteria needs to be met: Partial Response – Measurable Myeloma: One or more Both of the following criteria must be met *; *Transplant centers may not perform urine studies on a regular basis. In that case, only the ≥ 50 reduction in the serum M-protein is required for Heavy Chain and Light Chain Only Myeloma.
7/9/2020 MPN Response Criteria Modify Updated the response criteria for CR, Myelofibrosis CR, Partial Response, and Clinical Improvement by adding in the following: Requires all of the following maintained for a minimum of 12 weeks
7/8/2020 Appendix J: Reporting Comorbidities Modify Updated the reporting instructions for prior malignancy to be consistent with the reporting instructions listed on the Pre-TED (2400) manual.
7/8/2020 2450: Post-TED Remove Updated the instructions on when to report a cellular therapy for relapse, persistent, progressive disease to coincide with the Winter (January) 2020 release: Cellular therapy: Cellular therapy refers to the infusion of human or animal derived cells, which may or may not be modified or processed to achieve a specific composition. Examples include CAR T-cell, NK cell, and mesenchymal cell infusions as well as donor cellular infusions. Indicate “yes” if the recipient received any form of cellular therapy for relapse, persistent, or progressive disease or decreasing / loss of donor chimerism; hematopoietic cell transplantation should not be reported as cellular therapy, as this is captured in questions 7-13 of the Post-TED form. Indicate whether a cellular therapy was infused during the reporting period for relapsed, persistent, or progressive disease and go to question 119.
7/8/2020 2149: Respiratory Virus Post-Infusion Data Add Provided information on CRISPR testing for questions 2 – 3: Nasal swab / wash: a sample is collected from the nose using a swab or a small amount of saline solution. The sample is tested via polymerase chain reaction techniques that quantify the amount of viral RNA present or using novel CRISPR testing from respiratory swab RNA extracts. If the amount of viral RNA is above the upper limit of normal (found on the laboratory report), the result will be considered positive for the virus being tested. If the testing report does not clearly indicate whether the result was positive, negative, or equivocal, contact your center’s lab for clarification.
7/8/2020 2450: Post-TED Add Provided instructions how to report CRISPR testing for COVID-19 for questions 50 – 51: As a result of the global COVID-19 pandemic, the U.S. Food and Drug Administration granted Sherlock Biosciences an emergency use of authorization (EUA) for its COVID-19 diagnostic assay, CRISPR. Although still in its infancy in real-life application, positive results by this method should be reported, even if tandem testing by other method(s) (i.e., PCR) indicate a negative result. If the CRISPR results are unclear, seek physician clarification.
7/8/2020 2400: Pre-TED Modify Updated the time frame for reporting biomarkers in questions 103 – 112 (the blue information box) to be consistent with the augmented HCT comorbidity index: Complete questions 103 – 112 using the results measured the closest within four weeks prior to the start of the preparative regimen. Report results from the most recent assessment performed prior the start of the preparative regimen. The following are considered biomarkers according tot he augmented HCT comorbidity index.
7/7/2020 2100: Post-HCT Follow-Up Add A blue note box (red text) was added to questions 89 – 107 to provide guidance on how to report the GRID: If donor ID to report is a GRID, report the GRID in the non-NMDP ID data field, even if this is a NMDP donor. The GRID will be added as a separate data field during the next form revision of the Post-HCT (2100) Follow-Up Form.
7/7/2020 AML Response Criteria Modify Updated guidance on how to report disease status for recipients with MDS that transformed to AML – this instruction also applies to MPN and MF. For recipients with MDS / MPN / MF that transformed to AML Historically, for recipients who had residual MDS / MPN / MF following treatment for AML, the AML disease status was reported as either PIF or relapse (i.e., the recipient cannot be in an AML CR if there is evidence of MDS / MPN / MF at the time of assessment). However, this instruction was removed in May 2020 and an AML CR may be reported if there is residual MDS / MPN / MF as long as there are < 5% blasts in the bone marrow as well as 0% blasts in the peripheral blood.
7/7/2020 2402: Disease Classification Removed Updated question 92 by removing the strike through sentence: This question is optional for international centers. This question is required to be answered for both domestic and international centers.
7/7/2020 Appendix H: MDS/MPN Subytpes Modify Updated subtypes listed in Appendix H to coincide with the Spring (May) 2020 Form Revision.
7/6/2020 2011: ALL Pre-Infusion Added Provided clarification on how to answer question 10 for recipients with precursor T-cell and/or precursor B-cell lymphoblastic lymphoma (or lymphoma / leukemia): If the primary disease for infusion is precursor T-cell and/or precursor B-cell lymphoblastic lymphoma (or lymphoma / leukemia), report “No” for question 10 and continue with question 20.
6/30/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following note to reporting instruction for question 77-179: Report any observed toxicity or infection that occurs post-infusion that occurred in this reporting period, regardless of causality and whether or not treatment was administered (e.g chemotherapy due to relapse). The intent is to capture all toxicities diagnosed after the cellular therapy infusion. Although treatment given post-infusion may have the effect of re-activating the product and inducing toxicities (e.g. CRS), these toxicities should still be captured in this section of the form.
6/19/2020 Multiple Myeloma Response Criteria Modify Updated response criteria to show what criteria need to be met for measurable, non-measurable, and non-secretory myleoma. In addition, added clarification on how to report disease status when response was met in a time period and the confirmatory assessment was not performed until the next reporting period (red warning box).
6/12/2020 2400: Pre-TED Modify Updated the instructions on how to report intrathecal therapy as part of preparative regimen in question 127 – 128 to be consistent with Recipient Baseline (2000) manual: The “other drug” category should be used only if the drug is not one of the listed options. If an “other” drug is prescribed, list the name of the drug in question 128. Include any intrathecal drugs the recipient received for prophylaxis or treatment of CNS disease within 14 21 days prior to the start of the preparative regimen. Do not report additional sites of radiation (e.g., cranial boost) in the “other” drug category. If the recipient is assigned to the Comprehensive Report Forms by the form selection algorithm, the additional sites of radiation will be reported on the Recipient Baseline Form (Form 2000). If the recipient is assigned to TED Forms by the form track selection algorithm, the additional sites of radiation will not be reported.
6/11/2020 Appendix N: Drug Classifications Add Appendix N: Drug Classifications released
6/11/2020 2400: Pre-TED Modify Updated the instructions for question 120 on when the CIBMTR’s guidelines should be used to report the preparative regimen classification by removing (strike through text) and adding (red text) the following: Based on the CIBMTR operational guidelines below, report if the regimen was myeloablative, reduced intensity, or non-myeloablative. The determination of whether the intent of the regimen was reduced intensity or non-myeloablative should be based either on the center’s protocol at your center or the opinion of the physician overseeing the care of the recipient at your center. However, if the intent is not specified, the regiment intensity may be reported based on the CIBMTR operational guidelines below. However, if there’s a protocol utilized at your center that doesn’t fall within CIBMTR operational guidelines for regimen intensity, you may report the regimen intensity based on the protocol intent.
6/11/2020 2402: Disease Classification Add Clarification added on how to report the diagnosis date for recipients with congenital immunodeficiency in question 1: If the recipient was diagnosed prenatally (in utero) or was diagnosed with a congenital immunodeficiency, report the date of birth as the date of diagnosis.
6/11/2020 2402: Disease Classification Modify Updated the “Complete multiple disease sections of the Disease Classification Form?” column of Common Disease Transformations table above question 1 for the following transformations: MDS or MPN to AML: Yes – AML and MDS / or MPN; JMML to AML: Yes – AML and MDS /MPN (select questions only); CLL to NHL (i.e., Richter’s Syndrome): No Yes – NHL and CLL
6/11/2020 2402: Disease Classification Add Added red warning box at the top of question 1 to provide clarification (red text) on what assessments to report for the “at diagnosis” time point if a previous infusion has been reported to the CIBMTR and relapse or progression occurred: For many diseases, the CIBMTR data collection forms capture disease assessments at multiple timepoints pre- and post-infusion. If the indication for this recipient’s HCT / Cellular Therapy is relapsed / progressive disease and they have had a previous transplant that was reported to the CIBMTR, only disease assessments performed after the disease relapse / progression occurred need to be reported. In this case, the disease assessments “at diagnosis” would be the disease assessments performed at the time relapse / progression occurred (prior to the initiation of therapy). Some pre-infusion forms on the Case Report Form (CRF) track have different reporting rules, depending on if a pre-infusion CRF had been previously completed for the recipient. Carefully review the Disease-Specific CRF manuals for additional information.
6/11/2020 Waldenstrom’s Macroglobulinemia Response Criteria Add Provided clarification on how to report the disease status for recipients with WM on the Pre-TED Disease Classification (2402) Form by adding in the blue instructional box at the top of the response criteria and the italicized instructions below each response option.
6/9/2020 2402: Disease Classification Add Provided clarification to question 371 that the molecular response should only be reported based on the detected driver mutations.
6/9/2020 2116: PCD Post-Infusion Modify Update question 2 with the correct instructions: Indicate if the recipient had a concurrent or preceding plasma cell disorder. Many recipients progress to symptomatic myeloma from a preceding condition or have a concurrent plasma cell disorder, such as amyloidosis. This question will be auto-populated from the Plasma Cell Disorders (PCD) Pre-Infusion (2016) Disease Classification (2402) Form.
6/9/2020 2100: Post-HCT Follow-Up Add The following instructions (red text) were added to question 404 to provide clarification on how to report non-steroid agents for GVHD if the recipient passed away prior to discontinuation: If the recipient has died prior to the discontinuation of non-steroidal immunosuppressive agents used to treat or prevent acute and / or chronic GVHD, select “yes”
6/9/2020 4000: Cellular Therapy Essential Data Pre-Infusion Add Provided clarification (red text) on how to report heart valve comorbidity for question 115. Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by the most recent heart evaluation by an echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse. This does not include a documented medical history of heart valve disease.
6/9/2020 2400: Pre-TED Add Added clarification (red text) on how to report heart valve comorbidity for question 97. Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by the most recent heart evaluation by an echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse. This does not include a documented medical history of heart valve disease.
6/9/2020 Appendix J: Reporting Comorbidities Add Added clarification (red text) on how to report heart valve comorbidity. The presence of one or more of the following, found on the most recent heart evaluation by an echocardiogram:
• At least a moderate or severe degree of valve stenosis or insufficiency as determined by echo, whether the valve is mitral, aortic, tricuspid or pulmonary;
• Prosthetic mitral or aortic valve;
• Symptomatic mitral valve prolapse
6/8/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Updated the instructions for question 262 by as the instructions were incorrect. Indicate if disease was detected by a bone marrow examination. If disease was detected, If a bone marrow biopsy was performed at the time of evaluation for this reporting period, report “yes” for question 262 and report the date of the assessment in question 263. Continue with question 264.If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. If disease was detected on multiple bone marrow biopsies were performed during the reporting period, report the date of the assessment performed closest to the date of contact. If disease was not detected by a bone marrow examination biopsies were not performed at any time during the reporting period, or it is unknown if disease was detected any bone marrow biopsies were done, report “no” or “unknown” respectively and go to question 268.
6/8/2020 2000: Recipient Baseline Add Provided an example on how to report the overall busulfan exposure in questions 81-82.
6/5/2020 2018: LYM Pre-Infusion Add Provided clarification (see red text) on how to answer question 224 if therapy for DLBCL was not given between diagnosis and the start of the preparative regimen / infusion. If the recipient did not receive therapy between diagnosis of DLBCL and the start of the preparative regimen / infusion, leave question 224 blank, override the validation error using the code “unable to answer,” and specify in the comments the recipient did not receive therapy for DLBCL prior to the start of the preparative regimen / infusion.
6/5/2020 2018: LYM Pre-Infusion Modify Update the reporting instructions for question 201 (removed text is struck out and added text is in red): Indicate if the recipient received radiation to each site listed the extent of the radiation field.
6/3/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Add Provided clarification (see red text) on when to answer “not applicable” for questions 30 and 128. If testing for all of the listed driver mutations are negative, select “Not applicable (negative results).”
6/3/2020 2100: Post-HCT Follow-Up Add The following instructions (red text) were added to question 1 to provide clarification on how to report the contact date for the 1-year reporting period for recipients who receive an allogeneic transplant. If this form is being completed for the 1-year reporting period for a recipient who received an allogeneic transplant, ensure the reported contact date is ≥ Day 365. Review the 1-Year Date of Contact for Allogeneic Transplants instructions below for additional information
6/3/2020 2450: Post-TED Add The following instructions (red text) were added to question 1 to provide clarification on how to report the contact date for the 1-year reporting period for recipients who receive an allogeneic transplant. If this form is being completed for the 1-year reporting period for a recipient who received an allogeneic transplant, ensure the reported contact date is ≥ Day 365. Review the 1-Year Date of Contact for Allogeneic Transplants instructions below for additional information
6/3/2020 2402: Disease Classification Add Added clarification on how to report the pre-HCT disease status for recipient with amyloidosis who do not receive therapy. If therapy was not given to treat amyloidosis, report “Unknown”
6/3/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Add Provided clarification to questions 1, 4, and 5 that these questions are only enabled for PBSC and bone marrow products from non-NMDP donors.
5/29/2020 2402: Disease Classification Add Added clarification that chromosomal microarrays / chromosomal genomic arrays should be reported within the FISH assessments data fields.
5/28/2020 2450: Post-TED Add Added clarification that chromosomal microarrays / chromosomal genomic array should be reported within the FISH assessment data fields.
5/28/2020 2450: Post-TED Removed For question 84, removed instructions allowing chromosomal microarrays / chromosomal genomic array to be reported in the molecular assessment data fields. These assessments should not be reported within the molecular assessment data fields.
5/28/2020 2400: Pre-TED Modify Provided additional clarification on how to report the GFR if a range, “< X” or “> X” is listed and when the GFR calculator may be used.
5/21/2020 2400: Pre-TED Modify Provided additional clarification on how to report the ordered dose when pharmacokinetic testing is performed in question 129.
5/21/2020 2450: Post-TED Modify Provided clarification on how to report molecular abnormalities identified by other methods of assessment.
5/21/2020 4000: Cellular Therapy Essential Data Pre-Infusion Modify Q106- Clarified the instructions for reporting drug dose: Report the total prescribed dose that was actually given of the drug selected in question 104. Drug doses can be reported with one decimal place.
5/20/2020 4000: Cellular Therapy Essential Data Pre-Infusion Modify Q104- Clarified the instructions for reporting drug dose: For each drug listed, checking the box will indicate it was given as part of the lymphodepleting therapy used prior to the cellular therapy infusion. Report the total prescribed dose of each drug that was actually given. Do not report the prescribed dose or the daily dose. The pharmacy record or Medication Administration Record (MAR) should be used for determining the exact total dose given.
5/19/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Modify For question 13, specified that a constant temperature is usually found in cord blood shipping containers.
5/19/2020 2402: Disease Classification Modify Updated disease indication mentioned in guidance for answering question 101 from AML to ALL.
5/19/2020 2018: LYM Pre-Infusion Add Added specification that questions 62 and 146 should be answered for all Hodgkin histologies.
5/14/2020 AML Response Criteria Modify Modified guidance on recipients with MDS that transformed to AML (red box at the beginning) to include more context on guidance.
5/13/2020 2402: Disease Classification Modify Updated the following disease status criteria for hairy cell leukemia for question 378: Complete Remission, Stable Disease, and Progressive Disease.
5/13/2020 Multiple Myeloma Response Criteria Add Added blue information box in Complete Response section providing guidance on Serum or Urine Immunofixation.
5/13/2020 2400: Pre-TED Remove Removed the word “proven” from question 92 guidance. Removed verbiage from paragraphs defining “proven”.
5/13/2020 CML Response Criteria Add Added blue information box in the beginning, providing guidance on disease status tracking.
5/13/2020 2100: Post-HCT Follow-Up Modify For question 428-436, under Date of Diagnosis, updated first sentence to say “Report the specimen collection date of the positive microbiology culture or laboratory report as the diagnosis date”.
5/13/2020 2402: Disease Classification Modify Updated questions 23 and 115 so that, wherever indicated, “microarray” is now “chromosomal microarray”.
5/13/2020 2402: Disease Classification Modify Updated question 389 to include criteria the the PET or combination PET / CT scan must meet to answer “yes” for this question.
5/11/2020 4000: Cellular Therapy Essential Data Pre-Infusion Add Included instructions for questions that were added to the form (questions 111-113) intended to capture information on COVID-19 (SARS-CoV-2) infections.
5/11/2020 2450: Post-TED Add Added in questions 50-51 to capture information regarding COVID-19 (SARS-CoV-2) infections.
5/10/2020 MDS Response Criteria Modify Removed the MPN response criteria to align with the separation of the MDS and MPN disease-specific forms.
5/10/2020 MPN Response Criteria Add Separated the MPN response criteria to align with the new MPN disease-specific forms.
5/10/2020 2149: Respiratory Virus Post-Infusion Data Add Version 1 of the 2149: Respiratory Virus Post-Infusion Data section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2149.
5/10/2020 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Add Version 1 of the 2157: MPN Post-HCT section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2157.
5/10/2020 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion Add Version 1 of the 2057: MPN Pre-Infusion section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2057.
5/9/2020 MDS Post-HCT Modify Version 3 of the 2114: MDS Post-HCT section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2114.
5/9/2020 2014: MDS Pre-Infusion Modify Version 3 of the 2014: MDS Pre-Infusion section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2014.
5/9/2020 2400: Pre-TED Modify Version 6 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 6 corresponds to revision 7 of the Form 2400.
5/9/2020 2402: Disease Classification Modify Version 5 of the 2402: Pre-TED Disease Classification section of the Forms Instructions Manual released. Version 5 corresponds to revision 5 of the Form 2402.
5/8/20 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data Modify Updated units of measure for Questions 7-8 verbiage to “m/m 2”.
5/8/2020 2116: PCD Post-Infusion Add Added guidance to questions 124-125 to document unit of measure to the nearest tenth.
5/8/2020 2116: PCD Post-Infusion Add Added guidance to questions 329-330 to document unit of measure to the nearest tenth.
5/8/2020 2116: PCD Post-Infusion Add Added guidance to questions 326-327 to document unit of measure to the nearest tenth.
5/8/2020 2116: PCD Post-Infusion Add Added guidance to questions 127-128 to document unit of measure to the nearest tenth.
5/8/2020 2016: PCD Pre-Infusion Add Added guidance for question 139-140 to document unit of measure to the nearest tenth.
5/8/2020 2016: PCD Pre-Infusion Add Added guidance for question 142-143 to document unit of measure to the nearest tenth.
5/7/2020 2016: PCD Pre-Infusion Add Added guidance for question 192: “Question 192 is disabled and should not be answered. This question will be removed when the form is next revised”.
5/7/2020 2402: Disease Classification Modify Modified guidance on answering question 278, guidance now states “Question 278 is disabled and should not be answered. This question will be removed when the form is next revised”.
5/7/2020 2100: Post-HCT Follow-Up Add For questions 69-74, added phrase after bulleted items stating “If testing was performed as captured in question 64…”.
5/7/2020 2100: Post-HCT Follow-Up Add For question 64, added sentence “Questions 69-74 will then be disabled”.
5/7/2020 2400: Pre-TED Add For question 11, added the following guidance on zip codes: The zip or postal code is required for USA residents. The postal code is optional for Canadian residents. The question can be answered or left blank without error for Canadian residents.
5/5/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Added a clarification to the blue note box below question 9: If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CLL), Hodgkin Lymphoma (HL), Non-Hodgkin Lymphoma (NHL), or Multiple Myeloma (MM) best response should not be answered on this form. It will be captured on the corresponding disease form. The question should be left blank and please override the error at this time.
5/5/2020 4100: Cellular Therapy Essential Data Follow-Up Remove Removed blue note box: “This section will be disabled when disease specific forms are also being completed.”
4/7/2020 2450: Post-TED Add For question 41, added guidance on the intent of the question.
4/7/2020 2100: Post-HCT Follow-Up Add For question 303, added guidance on the intent of the question.
4/7/2020 2128: Aplastic Anemia Post-HCT Modify Updated red blood cell independence instructions (question 1) to make determinations based on the date of contact rather than the date of last report. Also added guidance that if the recipient was transfusion independent for part of the reporting period, but then is dependent again at the end of the reporting period, select “no” and continue to question 2.
4/7/2020 2553: VOD/SOS Add Added reporting guidance for scenario when drugs given for liver prophylaxis (red information box).
4/7/2020 2450: Post-TED Add Added guidance on reporting estimated dates after question 18 (blue information box).
4/7/2020 2100: Post-HCT Follow-Up Add Added guidance on reporting estimated dates (in blue informational box).
4/7/2020 2018: LYM Pre-Infusion Add Added sentence after question 80-81 stating Documentation from an RN who has been trained and authorized to determine performance scores may also be used.
4/7/2020 4000: Cellular Therapy Essential Data Pre-Infusion Add For question 109-100, added the following guidance for Karnofsky/Lansky scores: Documentation from an RN who has been trained and authorized to determine performance scores may also be used.
4/7/2020 2400: Pre-TED Add For question 85-86, added the following guidance on Karnofsky/Lansky score documentation: Documentation from an RN who has been trained and authorized to determine performance scores may also be used.
4/7/2020 Multiple Myeloma Response Criteria Add Under light chain only myeloma CR criteria, added negative immunofixation on both serum and urine samples (added serum to criteria).
4/7/2020 2018: LYM Pre-Infusion Modify Updated question numbers in section Q224-233: Disease Assessment at the Failure of the 1st Line of Therapy.
4/7/2020 2402: Disease Classification Add Added blue informational box before questions 23, 50, 77, 115, and 153 providing clarification on questions capturing molecular markers.
4/7/2020 2402: Disease Classification Remove Removed erythropoietic protoporphyria (EPP) as an example of another disease for question 364. Example now given is dystrophic epidermolysis bullosa (DEB).
4/7/2020 2402: Disease Classification Add Added red warning box with guidance on erythropoietic protoporphyria (EPP) after question 1.
4/6/2020 2400: Pre-TED Remove Removed the word “unrelated” from question 60, which now reads NMDP donor ID.
4/6/2020 Amyloidosis Response Criteria Add Added guidance on Free Light Chain Ratios.
4/6/2020 Plasma Cell Leukemia Response Criteria Add Added guidance on Free Light Chain Ratios.
4/6/2020 Multiple Myeloma Response Criteria Add Added guidance (blue box) on normal ranges for Free Light Chain Ratios.
4/6/2020 2814: Indication for CRID Assignment Add Added sentence to question 5 providing guidance on when to select ‘no’.
4/6/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Modify In section Q144-170: Donor/Infant Demographic Information, moved question 147 to question 159.
4/6/2020 2000: Recipient Baseline Remove Question 38 – removed CMV exception for serologic tests.
4/6/2020 2450: Post-TED Modify Updated hyperlink in Lost to Follow Up section for the Lost to Follow Up Tool.
4/6/2020 2450: Post-TED Remove Removed sentence in Lost to Follow Up section in introduction – If your center receives documented information that a recipient is alive or dead, the form should be filled out with the recipient survival status.
4/6/2020 2100: Post-HCT Follow-Up Modify Updated hyperlink in Lost to Follow Up section for the Lost to Follow Up Tool.
4/6/2020 2100: Post-HCT Follow-Up Remove Removed sentence in Lost to Follow Up section in introduction – If your center receives documented information that a recipient is alive or dead, the form should be filled out with the recipient survival status.
4/6/2020 Appendix A: Abbreviations and Definitions Add Added definitions for CPI, CTA, CVDR, and TCSA.
3/27/2020 2016: PCD Pre-Infusion Modify Modified sentence referring reader to question 188 for POEMS syndrome to recipient having a primary disease of monoclonal gammopathy of renal significance (MGRS) in the section Q157-187: Pre-HCT Therapy.
3/27/2020 2116: PCD Post-Infusion Modify Updated question numbers found in guidance for answering questions 54 and 91 in the section Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response.
3/27/2020 2116: PCD Post-Infusion Modify Updated question numbers found in guidance for answering questions 256 and 293 in the section Q253-311: Current Status of Amyloidosis for this Reporting Period.
3/27/2020 2116: PCD Post-Infusion Add Added sentence for guidance on answering question 251 in that says This question will not be enabled if the primary disease for transplant is monoclonal gammopathy of renal significance (MGRS). in the section Q211-252: Disease Status at the Time of Evaluation for this Reporting Period.
3/27/2020 2116: PCD Post-Infusion Add Added sentence for guidance on answering question 3 in that says This question will not be enabled if the primary disease for transplant is monoclonal gammopathy of renal significance (MGRS). in the section Q3-53: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy.
3/27/2020 2402: Disease Classification Modify Replaced “>” with “>/=” for guidance for question 324 in section Q306-339: Inherited Abnormalities of Erythrocyte Differentiation or Function.
3/27/2020 2402: Disease Classification Add Added sentence for question 298 in section Q254-301: Multiple Myeloma / Plasma Cell Disorder, stating This question will not be enabled if the primary disease for transplant is monoclonal gammopathy of renal significance (MGRS).
3/23/2020 Appendix J: Reporting Comorbidities Add Added link for determining pediatric BMI-for-age for obesity guidelines.
3/23/2020 2400: Pre-TED Modify In the Q88-113: Comorbid Conditions section, updated cardiac reporting guideline for congestive heart failure to include guidance on LVEF.
3/23/2020 2016: PCD Pre-Infusion Add Added guidance on LV straing percentage to questions 77-78 and 262-263.
3/23/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Modify Added guidance to questions 46 – 47, 58-59, 64-65, 70-71, and 76-77 regarding scenarios where center’s laboratory assay only measures viable cells.
3/23/2020 Amyloidosis Response Criteria Add Added definition for Very Good Partial Response (VGPR).
3/23/2020 2400: Pre-TED Add In the Q88-113: Comorbid Conditions section, added guidance to obesity reporting guideline for calculating BMI-for-age for pediatric patients.
3/23/2020 2402: Disease Classification Modify Updated “CLL” to “NHL” in the Common Disease Transformations table in section Q1-2: Primary Disease for HCT / Cellular Therapy.
3/23/2020 Appendix J: Reporting Comorbidities Add Added “(regardless of an LVEF >50% at the start of preparative regimen)” after congestive heart failure bullet point.
3/23/2020 2116: PCD Post-Infusion Add Added information about the LV strain percentage in the Q253-311: Current Status pf Amyloidosis for this Reporting Period section for questions 265-266.
3/23/2020 2116: PCD Post-Infusion Add Added information about the LV strain percentage in the Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response section for questions 63-64.
3/20/2020 2400: Pre-TED Modify In the Q46-83: Donor Information section, updated instructions for question 51 to include more specific criteria for a genetically modified product.
3/20/2020 2018: LYM Pre-Infusion Add Added guidance in introduction to Q166-223: Pre-HCT Therapy on scenario where recipient’s lymphoma histology transforms between diagnosis and start of preparative regimen.
3/11/2020 2128: Aplastic Anemia Post-HCT Modify Updated the platelet transfusion independence instructions by removing (strike through) and adding (red) text as indicated below:
Indicate if the recipient was platelet transfusion independent since the date of the last report on the date of contact for the current reporting period. A general guideline for platelet transfusion independence is that platelet transfusions have not been required for seven or more days.
If the recipient was platelet transfusion independent since the date of the last report on the date of contact, select “yes” and continue with question 5.
If the recipient was not platelet transfusion independent since the date of the last report on the date of contact, select “no” and continue with question 4.
If the recipient is transfusion independent for a portion of the reporting period, but then is dependent again at the end of the reporting period, select “no” and continue with question 4.
If it is unknown if the recipient was platelet transfusion independent since the date of the last report on the date of contact, select “unknown” and continue with question 5.
3/6/2020 2100: Post-HCT Follow-Up Add Added sentence in guidance for question 177 in section Q131-233: Acute Graft vs. Host Disease. Sentence provides guidance on scenario when maximum overall grade was achieved, but specific organ staging varies.
3/6/2020 2450: Post-TED Remove Removed “reasons other than” in guidance given on Cellular Therapy reporting for question 115 in section Q106-116: Relapse or Progression Post-HCT.
3/6/2020 2402: Disease Classification Modify Updated “report the value” to “report the percent” after question after questions 78-89 in section Q3-95: Acute Myelogenous Leukemia.
3/6/2020 2400: Pre-TED Modify In Q114-128: Pre-HCT Preparative Regimen section, updated instructions for question 124 – 125 to report drug doses to the nearest tenth.
3/6/2020 2400: Pre-TED Modify In Q114-128: Pre-HCT Preparative Regimen section, updated instructions for question 115 to report weight to the nearest tenth of a kilogram.
3/6/2020 2400: Pre-TED Modify Moved “arrhythmia” designation after question 93 in sectionQ88 – 113: Comorbid Conditions in the Documented Medical History list. Removed “other” listing after “Current Diagnosis at the Time of Pre-HCT Evaluation” list.
3/6/2020 Appendix J: Reporting Comorbidities Add Added “mild” specification in valve regurgitation listing for table of conditions that are not relevant transplant outcomes or risk.
3/6/2020 2450: Post-TED Add Added sentence in second paragraph of Question 106-116: Relapse or Progression Post-HCT regarding scenario where recipient receives a chemotherapy agent that is not listed.
3/5/2020 “2100: Post-HCT Follow-Up”:“https://www.cibmtr.org/manuals/fim/1/en/topic/2100 Modify Changed survival status text after Question 1 in section “”:https://www.cibmtr.org/manuals/fim/1/en/topic/q1-7-vital-statusQ1-5: Vital Status. Instead of completing the POst-TED Form reporting only survival status, the Survival Tool in the CIBMTR Data Management Guide should be used (link to Survival Tool provided after question 1).
3/5/2020 2450: Post-TED Modify Changed survival status text after Question 1 in section Q1-6: Survival. Instead of completing the POst-TED Form reporting only survival status, the Survival Tool in the CIBMTR Data Management Guide should be used (link to Survival Tool provided after question 1).
3/5/2020 2100: Post-HCT Follow-Up Add Added “demonstrated on labial biopsy (labial biopsy not required)” after question 303 in section Chronic Graft vs. Host Disease.
3/5/2020 2450: Post-TED Add Added “demonstrated on labial biopsy (labial biopsy not required)” after question 41 in section Graft versus Host Disease.
3/5/20 ALL Post-Infusion Add In section Disease Assessment at the Time of Best Response to HCT, guidance for question 1 on scenarios where 2111 is completed for both the cellular therapy and HCT track.
3/3/2020 2450: Post-TED Modify Added “allogeneic HCT” and “allogeneic HCT recipient whose” in the blue note box at the beginning of Q58-77: Chimerism Studies.
3/2/2020 Cellular Therapy Manuals Modify Updated and clarified when autologous cellular therapy data can be collected in the context of patient consent for research
3/2/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following sentence to reporting instruction for question 158-160: Other grade 4 toxicities / symptoms that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
3/2/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following sentence to reporting instruction for question 151-153: Other grade 3 toxicities / symptoms that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
3/2/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following sentence to reporting instruction for question 145-146: Other toxicities that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
2/27/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Modify Updated the text for questions 163-165 as indicated below (removed text is struck out and added text is in red):
If the recipient donor did not give autologous blood transfusion units, select “no” and continue with question 166.
2/21/2020 2110: AML Post-Infusion Modify Modified question 51-52 in the Disease Detection Since Date of Last Report section.
2/19/2020 Appendix G: Tracking Disease Status for Multiple Myeloma Modify Updated this appendix and the linked documents to remove the Near Complete Remission (nCR) disease response criteria. This disease response was removed in accordance with revision 4 of the Forms 2016/2116.
2/19/2020 2011: ALL Pre-Infusion Modify Updated number from 64 to 20 on ALL Pre-Infusion main page.
2/19/2020 2010: AML Pre-Infusion Modify Updated 69 to 32 on 2010: AML Pre-Infusion main page.
2/19/2020 2118: LYM Post-Infusion Data Modify Changed the instruction for for reporting question 89. This was previously updated in question 87 (see below) but modified the following instruction to question 89 (for additional clarity) by removing (strike through) and adding (red) text as indicated below.
The center does not need to repeat all disease-specific assessments (biopsies, i.e., CT (radiographic) or PET scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression. If a disease-specific assessment did not occur during this time period, please report the date of any disease related assessment (e.g. clinical assessments, labs, etc.) as the date assessed (Q88 or Q90) regardless of what the parent question states about the specific CT (radiographic) or PET criteria.
2/19/2020 2018: LYM Pre-Infusion Add Added information after Questions 1-2 and Questions 83-85 on double-hit or triple-hit lymphomas.
2/19/2020 2402: Disease Classification Add Added information about double-hit or triple-hit lymphomas to questions 236-237 in the Hodgkin and Non-Hodgkin Lymphoma section.
2/19/2020 2118: LYM Post-Infusion Data Add Added guidance in Disease Assessment at the Time of Best Response to HCT or Cellular Therapy, after question 1, on scenarios where the form is completed for both the cellular therapy and HCT tracks.
2/19/2020 ALL Post-Infusion Add In section Disease Assessment at the Time of Best Response to HCT, added scenarios in introduction for instances when form is completed for both the cellular therapy track and HCT track.
2/19/2020 2450: Post-TED Add Added information on tandem transplant in the introduction to the Disease Assessment at the Time of Best Response to HCT section. Added example to question 78.
2/19/2020 2450: Post-TED Add Added information on tandem transplant in the introduction to the Current Disease Status section. Added examples to question 117.
2/14/2020 2100: Post-HCT Follow-Up Add Added the following sentence to reporting instruction for question 486-487: If the recipient was intubated multiple times within the reporting period, please report the first date of intubation.
2/14/2020 2100: Post-HCT Follow-Up Add Added the following sentence to reporting instruction for question 488-489: If the recipient was extubated multiple times within the reporting period, please report the last date of extubation.
2/14/2020 Form 2111, Q95-130: Disease Status at the Time of Evaluation for This Reporting Period Modify Updated “51 – 84” to “48 – 80” in question 95.
2/10/2020 2804: CIBMTR Research ID Assignment Form Remove Removed the warning boxes above questions 8, 9, and 10 indicating that the fields were disabled. These fields were enabled at the time of the Winter 2020 release.
2/6/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Added table to display organ/system and applicable symptoms for grade 3 & 4 organ toxicities.
2/3/2020 2402: Disease Classification Modify Updated the instructions in the multiple myeloma section of the Disease Classification (2402) form to reflect that all cytogenetic abnormalities reported on the updated version of the form should be at diagnosis. Previous revisions of this form captured all cytogenetic abnormalities prior to the start of the preparative regimen.
1/30/2020 Appendix J: Reporting Comorbidities Remove Removed information on reporting “Other comorbidities” as this is no longer an option on the new Pre-TED (2400) form.
1/29/2020 2814: Indication for CRID Assignment Add Added the following instruction for how to report the date of transplant for intrauterine transplants:
Intrauterine Transplants
For intrauterine transplants, report the date of birth as the date of transplant to avoid errors from occurring in FormsNet3SM.
1/29/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Clarified best response valid options in Table 1.
1/27/2020 2100: Post-HCT Follow-Up Modify Added the following reporting instruction for the date of contact (question 1) in red below:
Enter the date of actual contact with recipient to determine medical status for this follow-up report. Acceptable evaluations include those from the transplant center, referring physician, or other physician currently assuming responsibility for the recipient’s care. Please capture a physician evaluation that falls within the appropriate range, if possible, rather than other types of patient contact that may be closer to the actual time point. If an evaluation was not performed at Day+100, at 6 months, or on the HCT anniversary, choose the date of the visit closest to the actual time point.
1/24/2020 2400: Pre-TED Modify Version 5 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 5 corresponds to revision 6 of the Form 2400.
1/24/2020 2402: Disease Classification Modify Version 4 of the 2402: Disease Classification section of the Forms Instruction Manual released. Version 4 corresponds to revision 4 of the Form 2402.
1/24/2020 2450: Post-TED Modify Version 4 of the 2450: Post-TED section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2450.
1/24/2020 2000: Recipient Baseline Modify Version 3 of the 2000: Recipient Baseline section of the Forms Instruction Manual released. Version 3 corresponds to revision 5 of the Form 2000.
1/24/2020 2004: Infectious Disease Markers Modify Version 4 of the 2004: Infectious Disease Markers section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2004.
1/24/2020 2005: Confirmation of HLA Typing Modify Version 4 of the 2005: Confirmation of HLA Typing section of the Forms Instruction Manual released. Version 4 corresponds to revision 7 of the Form 2005.
1/24/2020 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Modify Version 4 of the 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2006.
1/24/2020 2016: PCD Pre-Infusion Modify Version 3 of the 2016: Plasma Cell Disorders (PCD) Pre-Infusion Data section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2016.
1/24/2020 2116: PCD Post-Infusion Modify Version 3 of the 2016: Plasma Cell Disorders (PCD) Post-Infusion Data section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2116.
1/24/2020 2542: Mogamulizumab Supplemental Data Collection Add Version 1 of the 2542: Mogamuluizumab Supplemental Data Collection section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2542.
1/24/2020 4000: Cellular Therapy Essential Data Pre-Infusion Modify Version 4 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 4 corresponds to revision 6 of the form 4000.
1/24/2020 4003: Cellular Therapy Product Modify Version 3 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 3 corresponds to revision 3 of the Form 4003.
1/24/2020 4006: Cellular Therapy Infusion Modify Version 4 of the 4006: Cellular Therapy Infusion section of the Forms Instruction Manual released. Version 4 corresponds to revision 4 of the Form 4006.
1/24/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Version 5 section of the Forms Instruction Manual released. Version 5 corresponds to revision 5 of the Form 4100.
12/16/2019 F4100 Cellular Therapy Essential Data Follow-up Modify Added the following note about DCI/DLI infusions in questions 14 and 16. Check “not applicable” for DCI/DLI infusions where a preparative regimen was not given
Last modified: Nov 23, 2020

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