Getting Started

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
4/15/2024	2400: Pre-TED	Remove	Instructions reporting weight prior to prep updated in Q121 due to missing a sentence with the previous 4/3/2024 update: Report the recipient’s body weight just prior to the start of the preparative regimen as documented on the transplant (for radiation and/or systemic therapy) or admitting orders. The intent of this question is to report the weight used to calculate the preparative regimen drug doses. This weight may also be the same weight reported on the Recipient Baseline (2000) Form, if applicable. Report weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight. Even if the recipient does not receive a preparative regimen, the weight is still required.
4/12/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions clarified on which assessment date to report in Q132: Report the date the sample was collected for molecular testing. If disease was detected multiple times by this method of assessment in the reporting period, report the first assessment which detected disease. If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms
4/12/2024	MDS Post-HCT	Add	Disease Detection Since the Date of Last Report blue box and introduction added to the top of the Disease Detected section: Disease Detection Since the Date of Last Report:This section is intended to capture information only for recipients who relapse / progress, have persistent or minimal residual disease in this reporting period. If disease was not detected by the method of assessment, report No. If disease was detected by the method of assessment, the earliest instance in which disease was detected in the reporting period is reported. If multiple tests by a particular method have demonstrated evidence of disease during the reporting period, report the date / result of the earliest positive assessment(s) performed during the reporting period; For each method of assessment, report Yes if that method detected the recipient’s MDS (or markers of MDS) during the reporting period. If testing by a particular method (e.g., molecular makers, cytogenetic, flow cytometry, etc.) was done, but did not show evidence of disease during the reporting period, report No for that method. If testing for splenomegaly, hepatomegaly, molecular or cytogenetic markers / abnormalities, or bone marrow was not done during the reporting period or it is not known whether testing was performed, report Unknown for those methods. If testing by flow cytometry, extramedullary disease detection or other assessment was not done during the reporting period or it is not known whether testing was performed, report No for those methods.
4/12/2024	MDS Post-HCT	Modify	Instructions updated for molecular markers in Q100: If any molecular testing for molecular markers was performed and disease was detected during the reporting period, report Yes and go to question 101. If molecular testing for molecular markers was performed but did not detect disease at any time during the reporting period, report No. If molecular testing for molecular markers was not performed at any time during the reporting period, or it is unknown if testing was done, report No or Unknown respectively and go to question 109.
4/12/2024	MDS Post-HCT	Add	Clarification added to explain which date to report in Q102: Report the date the sample was collected for molecular testing. If disease was detected multiple times by this method of assessment in the reporting period, report the first assessment which detected disease. If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Question 105-202 blue box updated above Q105: Questions 105 – 202 are intended to capture information only for recipients who relapse / progress, have persistent or minimal residual disease in this reporting period. If disease was not detected by the method of assessment, report No. If disease was detected by the method of assessment, the earliest instance in which disease was detected in of disease detection by each method of assessment performed during the reporting period is reported. If multiple tests by a particular method have demonstrated evidence of disease during the reporting period, report the date / result of the earliest positive assessment(s) performed during the reporting period.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q117 to clarify these questions should only be reported if disease was detected by this assessment: Testing for driver mutations may be performed by different methods including next generation sequencing (NGS), polymerase chain reaction (PCR), microarray, and fluorescence in situ hybridization (FISH). If testing by any / all of these methods was performed, to assess JAK2, CALR, MPL and CSF3R, and at least one of the driver mutations were detected (i.e. positive for disease), report Yes for question 117 and continue with question 118. If testing was completed during the reporting period but did not show evidence of disease, report No. If testing was not done during the reporting period or it is unknown whether testing was completed, report Unknown. If tests for driver mutations were not performed, or it is unknown if testing was done, report no or unknown respectively and go to question 130.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q130 to clarify these questions should only be reported if disease was detected by this assessment: Molecular markers for disease refer to specific genetic sequences which are believed to be associated with the recipient’s primary disease. Testing for these sequences is often performed using PCR based methods; however, lower sensitivity testing, including FISH, may also be used to detect molecular markers. FISH testing for molecular markers should not be reported here. Once a marker has been identified, these methods can be repeated to detect minimal residual disease (MRD) in the recipient’s blood, bone marrow, or tissue. Molecular assessments include polymerase chain reaction (PCR) amplification to detect single specific disease markers; however, molecular methods are evolving and now include chromosomal microarray / chromosomal genomic array, Sanger sequencing, and next generation sequencing (e.g., Illumina, Roche 454, Proton / PGM, SOLiD). If any molecular testing for molecular markers was performed and disease was detected during the reporting period, report Yes and go to question 131. If molecular testing for molecular markers was not performed but did not detect disease at any time during the reporting period, report No*. If molecular testing was not done or it is not known if testing was done, report unknown.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q131 to clarify these questions should only be reported if disease was detected by this assessment: If a positive molecular marker was identified, select Yes and continue with question 132. If there were no molecular markers identified-, or it is unknown whether molecular markers were identified,- select no or unknown respectively, and continue with question 139.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q139 to clarify these questions should only be reported if disease was detected by this assessment: Flow cytometry assessment is a method of analyzing peripheral blood, bone marrow, or tissue preparations for multiple unique cell characteristics; its primary clinical purpose in the setting of MDS, MPN, and leukemias is to quantify blasts in the peripheral blood or bone marrow, or to identify unique cell populations through immunophenotyping. Flow cytometry assessment may also be referred to as “MRD” or minimal residual disease testing. If disease was detected via flow cytometry, select Yes and continue with question 140. If flow cytometry was done but disease was not detected or it is unknown if flow cytometry was done, select No and continue with question 148. If disease was not detected via flow cytometry or it is unknown if disease was detected via flow cytometry, select no and continues with question 148.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions updated in Q149 to clarify these questions should only be reported if disease was detected by this assessment: Indicate whether FISH studies detected disease at any time during the reporting period. If FISH detected disease, select Yes go to question 150. Report No for question 149 and go to question 158 in any of the following cases: FISH testing was not performed during the reporting period; or FISH testing was done but abnormalities were not detected; or FISH testing was attempted, but no assessments could be performed during the reporting period (e.g., insufficient sample); or It cannot be determined whether FISH testing was performed during the reporting period.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions updated in Q158 to clarify these questions should only be reported if disease was detected by this assessment: Indicate whether karyotyping studies detected abnormalities at any time during the reporting period. If karyotyping detected disease, select Yes go to question 159. Report no for question 158 and go to question 167 in any of the following cases: karyotyping was not performed during the reporting period; or karyotyping was performed but not abnormalities were detected; or karyotyping was attempted, but no assessments could be performed during the reporting period (e.g., insufficient sample); or it cannot be determined whether karyotyping was performed during the reporting period.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions updated in Q167 to clarify these questions should only be reported if disease was detected by this assessment: If a bone marrow biopsy detected disease during the reporting period, report Yes for question 167 and report the date of the positive assessment in question 168. Continue with question 169. 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 multiple bone marrow biopsies detected disease, report the date of the earliest positive assessment performed during the reporting period. If bone marrow biopsies did not detect disease at any time during the reporting period, report No. or If it is unknown if any bone marrow biopsies were done, report no or unknown respectively and go to question 174.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Example 1 added to the intro of the infection prophylaxis section: Example 1: A recipient is admitted for transplant on day -6, 1/2/2022, with the transplant occurring on 1/8/2022. The recipient receives the following medications based on the medication administration record: Ciprofloxacin started on 1/07/22 Ciprofloxacin is discontinued on 1/14/22, and the recipient begins treatment for a neutropenic fever with Cefepime and Vancomycin on the same day. Valacyclovir started on 1/7/2022. Fluconazole started on 1/7/2022. Fluconazole is discontinued on 1/16/22, and the recipient begins Micafungin due to a toxicity on the same day. Bactrim given from 1/2/22 to 1/6/22 and again at discharge. In this scenario, the infection prophylaxes would be reported as the following: Antibacterial prophylaxis: Ciprofloxacin Cefepime and vancomycin were empiric treatments (not prophylaxis) for a neutropenic fever and thus would not be reported as the antibacterial prophylactic drugs. Antiviral prophylaxis: Valacyclovir Antifungal prophylaxis: Fluconazole Micafungin was the second antifungal administered and likely still served as prophylaxis. However, the switch from Fluconazole to Micafungin was due to the recipient’s increase in liver function tests (AST, ALT, etc.), and thus is not reported as an antifungal prophylaxis since only the first prophylactic drug administered during the reporting period is reported. Anti-PJP prophylaxis: Bactrim
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis in Q212: Report the first antibacterial drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antibacterial drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis for Q217: Report the first antiviral drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antiviral drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. If the start date is prior to the start of the preparative regimen and the start date is unknown, report the date as seven days prior the start of the preparative regimen. Only one antiviral drug may be reported.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis in Q222: Report the first antifungal drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antifungal drugs started as prophylaxis prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. Only one antifungal drug may be reported. If the start date is prior to the start of the preparative regimen and the start date is unknown, report the date as seven days prior to the start of the preparative regimen.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis in Q225: Report the first anti-pneumocystis (PJP) drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include anti-pneumocystis (PJP) drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. Only one anti-pneumocystis (PJP) drug may be reported.
4/4/2024	2000: Recipient Baseline	Add	Plasma vs Serum Samples blue box added above Q4
4/4/2024	2400: Pre-TED	Add	Plasma vs Serum Samples blue box added above Q106
4/4/2024	Appendix C: Cytogenetics	Add	The Reporting Other FISH Results section added to the FISH subsection
4/4/2024	Appendix C: Cytogenetics	Add	The Reporting Other Karyotype Results section added to the Karyotype subsection
4/3/2024	2100:Post-Infusion Follow-Up Form	Add	Further clarification added to Q186 to explain the clinician’s score should be reported: Report the maximum chronic GVHD involvement, based on the opinion of the clinician. (i.e., clinical grade), since the date of the last report. The intent of this question is to capture the maximum grade based on the best clinical judgment. If both the global severity and the score based on the clinician’s opinion is documented, report the clinician score. If the maximum clinical grade is not documented, request documentation from the recipient’s primary care provider. Guidelines on how to report the maximum grade of chronic GVHD are outlined below: 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 Indicate Unknown if there is no information about the recipient’s GVHD status for the reporting period. This option should be used sparingly and only when no judgment can be made about the presence or absence of GVHD in the reporting period.
4/3/2024	2450: Post-TED	Add	Further clarification added to Q39 to explain the clinician’s score should be reported: Report the maximum chronic GVHD involvement, based on the opinion of the clinician. (i.e., clinical grade), since the date of the last report. The intent of this question is to capture the maximum grade based on the best clinical judgment. If both the global severity and the score based on the clinician’s opinion is documented, report the clinician score. If the maximum clinical grade is not documented, request documentation from the recipient’s primary care provider. Guidelines on how to report the maximum grade of chronic GVHD are outlined below: 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 Indicate Unknown if there is no information about the recipient’s GVHD status for the reporting period. This option should be used sparingly and only when no judgment can be made about the presence or absence of GVHD in the reporting period.
4/3/2024	2400: Pre-TED	Modify	Instructions for reporting the weight prior to prep were updated in Q121: Report the recipient’s actual body weight just prior to the start of the preparative regimen as documented on the transplant (for radiation and/or systemic therapy) or admitting orders. The intent of this question is to report the actual weight used to calculate the preparative regimen drug doses. This may be the same weight reported on the Recipient Baseline (2000) Form. at the time the preparative regimen starts (which may be different than the weight used to determine preparative regimen doses). This weight is usually documented on the transplant orders (for radiation and/or systemic therapy) or admitting orders. Report weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight.
4/3/2024	2402: Disease Classification	Remove	Removed the red waring box above Q469, stating that Q469 – 501 only comes due for transfusion dependent thalassemia.
4/3/2024	2900: Recipient Death	Modify	Instructions for LTF updated due to centers now being able to reset LTF forms on their own: Occasionally, centers may lose contact with recipients for a variety of reasons, including the recipient’s moving, changing physicians, or death. After attempts to contact the recipient or referring physician have failed, the recipient may be declared lost to follow-up. If your center later receives documentation that a recipient is dead, report this on the appropriate follow-up form for the time period in which the recipient died. This may require resetting of a form that was previously made Lost to Follow Up (LTF) or Survival (SUR). contacting CIBMTR Center Support to open a form for completion. For example, %(color-red)This may happen when a center may only becomes aware of the death after it has reported that the recipient is lost to follow-up. To reset the form, click the blue counterclockwise arrow icon. If a recipient dies a year and a half after transplant with no contact at your center, and a lost to follow-up form is completed for the two-year time point, submit a ticket through CIBMTR Center Support to make the two-year follow-up form due.
4/3/2024	2005: Confirmation of HLA Typing	Remove	Instructions on when 2005 comes due updated due to changes related to Fall 2022 release: A separate Form 2005 should be completed for each non-NMDP donor, recipient, or cord blood unit; however, only the recipient form is required for syngeneic transplants and HLA identical siblings. Both maternal and paternal typing should be submitted, if available, for all mismatched related donor transplants on the CRF track. Additionally, cord blood maternal typing should be submitted, if available, for all unrelated cord blood transplants on the CRF track. Maternal typing is requested in addition to, and not in place of, typing performed on the donor / CBU. Typing on the donor / CBU must be reported when meeting any of the descriptions above.
2/23/2024	2402: Disease Classification	Add	Instructions and example added to Q24, 51, and 78 on how to determine the FLT3-ITD allelic ratio: The allelic ratio data field is intended to capture the ratio of the FLT3-ITD mutation. This data field does not collect the allelic frequency, the allelic frequency is used to calculate the allelic ratio. The FLT-3 ITD allelic ratio (or signal ratio) compares the number of ITD-mutated alleles to the number of wild-type (normal) alleles. If the allele frequency was assessed, the ITD-mutated allele frequency will be documented on the molecular report; however, the wild-type allele frequency will need to be calculated. To determine the wild-type allele frequency, subtract the ITD-mutated allele frequency from 1 (or 100.0). After determining the wild-type allele frequency, the allelic ratio can be assessed. To calculate the allelic ratio, divide the mutant allele frequency by the wild-type (normal) allele frequency.
4/2/2024	2011: ALL Pre-Infusion	Add	Purpose of Therapy for Bridging Therapy blue box added above Q28: Purpose of Therapy for Bridging Therapy For recipients who receive bridging therapy, report this lines of therapy as Consolidation or Treatment for relapsed disease. If the recipient didn’t relapse, report the intent as Consolidation, otherwise, report the intent as Treatment for disease relapse.
3/13/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions added on when to use the medication toxicity for liver impairment in Q275: Medication toxicity: If the liver abnormality (i.e., abnormal LFT values) is associated with drug initiation, abnormalities improve with cessation, and / or there are no other causes for the changes.
3/13/2024	2400: Pre-TED	Modify	The red warning box above Q147 updated to clarify this section is now disabled and will be updated with the next revision of the Pre-TED (2400) form.
3/13/2024	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated instructions in Q9 to clarify RCI-BMT is now known as CIBMTR CRO Services: If the study sponsor is reported as BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, PedAL, or Investigator initiated, specify the ClinicalTrials.gov identification number. The letters “NCT” do not need to be included in the field. I
3/13/2024	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated hyperlink in Q8 for CIBMTR CRO Services: https://cibmtr.org/CIBMTR/Studies/Research-Programs/Clinical-Trials-Support/CRO-Services
3/13/2024	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated instructions in Q8 to clarify RCI-BMT is now known as CIBMTR CRO Services: For the infusion being reported on this form, indicate if the recipient is a registered participant with BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, a Corporate / Industry trial, EudraCT, UMIN, an investigator-initiated trial and/or another clinical trial sponsor, regardless if that sponsor uses CIBMTR forms to capture outcomes data.
3/8/2024	General Instructions	Add	General Number Reporting Guidelines added to the General Guidelines for Completing Forms subsection
3/8/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Omidubicel and Orca-T Products blue box added above Q35: Omidubicel and Orca-T Products If the product is Omidubicel, select Ex vivo expansion for the first product and Other manipulation for the second product – specify the manipulation as ‘Negative fraction.’ If the product is Orca-T, report the manipulation as CD34 enriched.
3/8/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Omidubicel and Orca-T Products blue box added above Q34: Omidubicel and Orca-T Products If the product is Omidubicel or Orca-T, select Yes the product was manipulated.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q76: Omidubicel and Orca-T Products: If the product is Omidubicel, report the number of products intended to achieve hematopoietic engraftment as two and complete two HCT Product and Infusion (2006) forms. If the product is Orca-T, report the number of products intended to achieve hematopoietic engraftment as one and complete one HCT Product and Infusion (2006) forms and two Cellular Therapy Product (4003) forms.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q75: Omidubicel and Orca-T Products: If the product is Omidubicel, report the number of products from the donor as two. If the product is Orca-T, report the number of products from the donor as three.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q47: Omidubicel and Orca-T Products: If the product is Omidubicel or Orca-T, report No, the product was not genetically modified.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q45: Omidubicel and Orca-T Products: If the product is Omidubicel, report the product type as CBU. If the product is Orca-T, report the product type as BM.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q42: Omidubicel and Orca-T Products: If the product is Omidubicel or Orca-T, select No for multiple donors.
3/7/2024	2199: Donor Lymphocyte Infusion	Modify	Added text for clarification of therapy timepoint: This question is intended to capture if the recipient had received treatment therapy to treat disease at any time prior the DLI.
2/23/2024	2402: Disease Classification	Add	Instructions updated in Q408 to clarify Deauville scores should not be determined without physician / radiologist clarification: Report whether the five-point PET score is known. This information is typically documented in the PET report. Consult the appropriate transplant physician if the results are unclear. If Known, report the score. Otherwise, report Unknown. If the PET scan result is only documented as an ‘X’, report this as Unknown. If multiple scores are documented, report the highest. If a score is not documented within the PET (or PET/CT) scan, report Unknown or work with the physician / radiologist to determine if a score can be reported. Do not determine Deauville scores without seeking physician / radiologist clarification.
2/21/2024	2400: Pre-TED	Add	ATG / Campath blue note box added above Q106
2/13/2024	2100:Post-Infusion Follow-Up Form	Remove	Update the Corticosteroids blue note box above Q121 for clarification: Corticosteroids are captured differently depending on whether they are used topically or systemically. Use the following guidelines when determining how to report corticosteroids used to treat acute GVHD: Topical Creams for Skin: Do not report topical ointments or creams used to treat skin GVHD including corticosteroid creams such as Triamcinolone or Hydrocortisone. Other Topical Treatments: Certain corticosteroid treatments are inhaled or ingested, but are not absorbed and are therefore considered topical. Examples include beclomethasone and budesonide. If these treatments are given for acute GI GVHD during the reporting period, report Yes for Corticosteroids. If these treatments were given for other organ involvement of GVHD, contact the CIBMTR Customer Service Center to determine the best option for reporting this therapy. Systemic Treatments: Systemic administration of corticosteroids, including use of prednisone and dexamethasone, should be reported in Select systemic treatment used to treat acute GVHD).
2/13/2024	2402: Disease Classification	Add	Instructions updated in Q408 to clarify Deauville scores should not be determined without physician / radiologist clarification: Report whether the five-point PET score is known. This information is typically documented in the PET report. Consult the appropriate transplant physician if the results are unclear. If Known, report the score. Otherwise, report Unknown. If the PET scan result is only documented as an ‘X’, report this as Unknown. If multiple scores are documented, report the highest. If a score is not documented within the PET (or PET/CT) scan, work with the physician / radiologist to determine if a score can be reported. Do not determine Deauville scores without seeking physician / radiologist clarification.
2/12/2024	POEMS Response Criteria	Add	Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine.
2/12/2024	Multiple Myeloma Response Criteria	Add	Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine.
2/12/2024	Plasma Cell Leukemia Response Criteria	Add	Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine.
2/12/2024	2900: Recipient Death	Add	Instructions for when ‘autopsy pending’ is reported were updated: If Autopsy pending, the form will not go to complete (CMP) status until the autopsy results are reported. The form may be submitted with question 2 as Autopsy pending, but the form will remain in saved (SVD) status until it is updated with the results. Once the autopsy results are known, update question 2, and the Primary cause of death, if applicable, to ensure all pertinent causes of death are reported, then resubmit in order to complete the form. All pertinent causes of death should be reported on the second Recipient Death Data (2900) form.
2/12/2024	2402: Disease Classification	Add	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in the Laboratory Studies at Diagnosis of MDS blue box: Report laboratory results closest to the diagnosis date and prior to the start of first treatment of the primary disease for which the HCT is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis.
2/12/2024	2402: Disease Classification	Add	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in the Laboratory Studies at Diagnosis of MPN blue box: Report laboratory results closest to the diagnosis date and prior to the start of first treatment of the primary disease for which the HCT is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis.
2/12/2024	2402: Disease Classification	Add	Instructions clarified when to report more than one heavy / light chain in Q415 Indicate the heavy and / or light chain type for the recipient’s disease. Select all that apply. More than one heavy and / or light chain type should only be selected for recipients diagnosed with biclonal multiple myeloma.
1/26/2024	2100:Post-Infusion Follow-Up Form	Add	Example 7 added to Q1: Example 7. The recipient had a subsequent auto transplant for graft failure: The recipient has their first auto transplant on 3/1/23 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/23. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period since a new Pre-TED (2400) / Disease Classification (2402) is not required for auto rescues.
1/26/2024	2450: Post-TED	Add	Example 7 added to Q1: Example 7. The recipient had a subsequent auto transplant for graft failure: The recipient has their first auto transplant on 3/1/23 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/23. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period since a new Pre-TED (2400) / Disease Classification (2402) is not required for auto rescues.
1/26/2024	2542: Mogamulizumab Supplemental Data Collection	Add	Version 2 of the 2542: Mogamuluizumab Supplemental Data Collection section of the Forms Instruction Manual released. Version 2 corresponds to revision 2 of the Form 2542.
1/23/2024	4101: Post-Cellular Therapy Follow-Up	Add	Added the text in red: CAR-T cells that target antigens (e.g., CD19) on B-cells do not distinguish between cancerous and normal B-cells. As result, the recipient can develop B-cell aplasia (low number or absence of B-cells). B-cell aplasia can be used as a surrogate to track persistence of the product. If the recipient has B-cell aplasia, then the product may still be present. Examples include (but not limited to) “cellular immunology report”, “lymphocyte subsets”, or “B-cell panel” of applicable tests that will show B-cell populations.
1/19/4	4100: Cellular Therapy Essential Data Follow-Up	Add	Added text in red to the first blue box above question 12: If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL), Non-Hodgkin Lymphoma (NHL), or Multiple Myeloma (MM) and there is a corresponding disease form, best response is not reported on this form.
1/16/2024	4100: Cellular Therapy Essential Data Follow-Up	Add	Added the following text to question 85: Lower scores are associated with a higher level of encephalopathy. Report the lowest score of any evaluation from the reporting period. Unable to complete assessment should be selected when an assessment was started and couldn’t be finish for any reason or the recipient couldn’t perform the evaluation. This should be used rarely since evaluations may be given multiple times a day.
1/15/24	4101: Post-Cellular Therapy Follow-Up	Modify	Added the text in red: Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This occurs when disease relapses and the tumor develops partial or complete loss of the tumor antigen. This may be determined by testing (e.g. T-cell subset profile) on the blood and/or bone marrow showing absence of the tumor antigen targeted by the cellular therapy they received. Common testing methods are listed in question 6. Example 1: A recipient has a CD19 expressing disease prior to the cell therapy infusion, such as acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). The recipient is given a CD19-directed CAR T-cell therapy, achieves a CR then relapses. At the time of relapse, the T-cell subset profile shows the absence of CD19 B Cells. This means the leukemia/lymphoma cells no longer express CD19.
1/15/2024	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added the text in red: Disease relapse or progression can be documented by a variety of methods including molecular, flow cytometry, cytogenetic/fluorescent in situ hybridization (FISH), radiographic or hematological/clinical. The intent is to captures any new relapse or progression event that occurred in the reporting period, not just the initial relapse or progression. Report Yes if any new disease relapse or progression was detected by any one of the methods in the current reporting period and report the first date (YYYY-MM-DD) of the relapse or progression detected.
1/12/24	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the red warning box regarding clinical trials from question 9: Products that are commercially available are no longer under a clinical trial. However, if a commercial product is being used within the context of a clinical trial for a new indication or the product is “out of specification”, report the clinical trial in this question.
1/12/24	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the red warning box regarding clinical trials from question 8: Products that are commercially available are no longer under a clinical trial. However, if a commercial product is being used within the context of a clinical trial for a new indication or the product is “out of specification”, report the clinical trial in this question.
1/10/2024	Appendix D: How to Distinguish Infusion Types	Modify	Added definitions for genetically modified vs not genetically modified cellular therapy products.

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