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General Guidelines for Completing Forms

General Instructions » General Guidelines for Completing Forms

Fields Requiring a Date For fields that require a date, if an exact date is not known use the process listed below. This process should be used only if the dates fit within the logical timeframe of the form (i.e. contact date, diagnosis date, relapse date, etc). To…

General Instructions

General Instructions

The General Instructions section of the Forms Instruction Manual contains several sections meant to aid in forms completion. Introduction Key Fields & Signature Lines General Guidelines for Completing Forms Manual Updates: Sections of the Forms Instruction Manual…

2814: Indication for CRID Assignment

Recipient Assignment, Indication, and Information Manuals » 2814: Indication for CRID Assignment

The Indication for CRID Assignment (Form 2814) collects information to initiate CIBMTR reporting on appropriate research or data collection forms. This form must be completed for the first indication requiring the individual to register for a CIBMTR Research ID (CRID).…

Q120-121: Reason for Transplant

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q120-121: Reason for Transplant

Questions 120 – 121: What was the PRIMARY reason for infusion? Specify the recipient’s primary reason for the infusion. If the indication for transplant is not listed, report Other and specify the reason in question 121. If there are multiple indications for…

Q58-77: Indication for Cellular Therapy

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q58-77: Indication for Cellular Therapy

Question 58: What was the primary indication for performing treatment with cellular therapy? From the list provided, select the primary indication for which the recipient is receiving the cellular therapy. If the indication is in the list below and the cell therapy…

Q18-37: Antiviral Therapy for Hepatitis

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q18-37: Antiviral Therapy for Hepatitis

This section is related to antiviral therapy given to the recipient. Question 18: Was therapy given for hepatitis since the date of the last report (or, if this is the first post-HCT report, since diagnosis)? Hepatitis antiviral therapy is intended to prevent…

Q95-166: Post-HCT Treatment for Immune Deficiency

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q95-166: Post-HCT Treatment for Immune Deficiency

Question 95: Was treatment given (since the date of last report)? The questions below regarding prophylactic anti-infection and immunosuppressant drugs, refer to supportive therapy used to treat or prevent the sequelae (or condition as a result of the disease) such as…

Q116-191: Pre-HCT Therapy for Immune Deficiency

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q116-191: Pre-HCT Therapy for Immune Deficiency

Question 116: Was treatment given (between diagnosis and prior to the preparative regimen)? Since immune deficiencies are non-malignant diseases caused by genetic mutations, hematopoietic stem cell transplant is the main curative treatment at this time. Other…

Appendix G: Tracking Disease Status for Multiple Myeloma

Appendices » Appendix G: Tracking Disease Status for Multiple Myeloma

Successfully tracking and reporting disease status for multiple myeloma requires a understanding of the different methods of assessment, away of organizing relevant test results, and the ability to identify the correct baseline against which changes in test results can…

Q1-2: Primary Disease for HCT / Cellular Therapy

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q1-2: Primary Disease for HCT / Cellular Therapy

*Disease Classification Questions The newest versions of the TED Forms use the World Health Organization (WHO) disease classifications. The Disease Classification questions contain all of the established WHO disease types and subtypes. The “other, specify” category…

Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Complete questions 35-54 for allogeneic transplants only; if donor information is unknown, leave the data field blank. Complete all data fields for which relevant donor information is documented and available to the CIBMTR center completing the form. Question 35: Did…

Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Question 7: Did the recipient receive therapy for hepatitis prior to HCT? Hepatitis antiviral therapy is intended to prevent progression of the disease and minimize sequelae of infection. The National Institutes of Health (NIH) in the United States recommends…

Q106-167: Post-HCT Treatment for Wiskott-Aldrich Syndrome

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q106-167: Post-HCT Treatment for Wiskott-Aldrich Syndrome

Question 106: Was any treatment given for relapsed, persistent, or progressive disease (since the date of last report)? Following transplant, additional therapy may be given for relapsed, persistent, or progressive disease. Low lymphocyte counts, new or persistent…

Q253-311: Current Status of Amyloidosis for this Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q253-311: Current Status of Amyloidosis for this Reporting Period

!Complete questions 253-311 for amyloidosis patients only. If amyloidosis was not reported as the primary disease for infusion (question 1) or as a preceding / concurrent disorder (question 2), skip to question 312. *Current Disease Status The center does not need to…

Q312 – 343: Current Status of POEMS Syndrome for This Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q312 – 343: Current Status of POEMS Syndrome for This Reporting Period

!Complete questions 312-343 for POEMS patients only. If POEMS was not reported as the primary disease for transplant (question 1) or as a preceding / concurrent disorder (question 2), submit the form. Questions 312-313: Specify POEMS clinical features (check all that…

Q77: Infection Status at the Time of Evaluation for this Reporting Period

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q77: Infection Status at the Time of Evaluation for this Reporting Period

Question 77: What was the infection status at the time of evaluation for this reporting period? Report the status of the viral infection on the date of contact for this reporting period (refer to the corresponding follow-up form) based on the primary care provider’s…

Q195-198: Disease Status at Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q195-198: Disease Status at Time of Evaluation for this Reporting Period

Question 195: What was the disease status? Report the recipient’s disease status at the time of evaluation for this reporting period. Ensure the disease status is consistent with the international working group criteria provided in the in CML Response Criteria…

Q95-130: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q95-130: Disease Status at the Time of Evaluation for This Reporting Period

Question 95: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 48-80), without subsequent therapy? This section of the form is intended to capture the most recent disease assessment. The most recent…

Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2128: Aplastic Anemia Post-HCT » Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period

Questions 1 – 2: Was the recipient red blood cell (RBC) transfusion independent for the entire reporting period? Indicate if the recipient was RBC transfusion independent for the entire reporting period. Some discretion may be required if the recipient received a…

Q31-41: Laboratory Studies at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q31-41: Laboratory Studies at the Time of Evaluation for This Reporting Period

Questions 31-32: Serum ferritin Indicate whether serum ferritin level was “known” or “unknown” during the reporting period. If “known,” report the value and unit of measure documented on the laboratory report in question 32. If there are multiple values…

Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Question 87: What is the current disease status? (by CT (radiographic) criteria) Indicate the current disease status, based on radiographic criteria, using the international working group criteria provided in LYM Response Criteria section of the Forms Instruction…

Q78-79: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q78-79: Disease Status at the Time of Evaluation for this Reporting Period

Question 78: What is the current disease status? Indicate the disease status of WM or LPL at last evaluation during the reporting period. See WM Response Criteria for disease status definitions. The center does not need to repeat all disease-specific assessments…

Q203-287: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion » Q203-287: Disease Status at the Time of Evaluation for this Reporting Period

Question 203: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 105-202), without subsequent therapy? This section of the form is intended to capture the most recent disease assessments performed in…

Q89-113: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q89-113: Disease Status at the Time of Evaluation for This Reporting Period

Question 89-90: Were tests for molecular markers performed (e.g. PCR)? If testing for molecular markers was performed during the reporting period, report “yes” and report the sample collection date of the most recent testing performed during the reporting period…

Q59-77: Laboratory Studies at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q59-77: Laboratory Studies at the Time of Evaluation for this Reporting Period

These questions are intended to determine the status of the recipient at the last evaluation for this reporting period. Testing may have been performed multiple times during the reporting period; report the most recent laboratory values. Reported values should be…

Q21-22: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT » Q21-22: Disease Status at the Time of Evaluation for this Reporting Period

Question 21: What was the disease status? Indicate the disease status of JMML as of the last evaluation during the reporting period. See JMML Response Criteria for disease status definitions. The center does not need to repeat all disease-specific assessments…

Q104-144: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q104-144: Disease Status at the Time of Evaluation for This Reporting Period

Question 104: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 51-89), without subsequent therapy? This section of the form is intended to capture the most recent disease assessment. The most…

Q172-236: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q172-236: Disease Status at the Time of Evaluation for this Reporting Period

Question 172: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 89-152), without subsequent therapy? This section of the form is intended to capture the most recent disease assessments performed in…

Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

For questions 211-252, report values obtained at the last evaluation for this reporting period. If testing is performed multiple times during the reporting period, report the values obtained at the last evaluation in the reporting period. Questions 211-212: Serum…

Q1-2: Tepadina® Stop Date

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q1-2: Tepadina® Stop Date

Questions 1 & 2: Tepadina® stop date !Questions 1-2 can only be completed on the 100 day follow-up form. These questions will be skipped for all subsequent reporting periods. Indicate if Tepadina® stop date is “Known” or “Unknown” in question 1. Start date…

Q29-42: Laboratory Studies at Diagnosis

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q29-42: Laboratory Studies at Diagnosis

Question 29-42: Laboratory studies at diagnosis These questions are intended to determine liver function at the time of VOD/SOS diagnosis. Report testing performed on the date of diagnosis. If testing was not performed on the date of diagnosis, report the closest…

Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Question 43: Was a disease relapse or progression detected since the date of last report? Refer to the international working group criteria provided in CLL Response Criteria section of the Forms Instructions Manual for more information on how to determine recurrence…

Q14-31: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q14-31: Laboratory Studies at Diagnosis

All values reported in questions 14-31 must reflect testing performed prior to any treatment of AML. If testing was not performed near the time of diagnosis (within approximately 30 days) and prior to the initiation of treatment, the center should report “Unknown”…

Q1-19: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q1-19: Laboratory Studies at Diagnosis

All values reported in questions 1-19 must reflect testing performed prior to any treatment of ALL. If testing was not performed near the time of diagnosis (within approximately 30 days) and prior to the initiation of treatment, the center should report “Unknown”…

Q74-148: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q74-148: Pre-HCT or Pre-Infusion Therapy

*Richter’s Transformation If completing this form for a recipient whose disease has undergone Richter’s transformation prior to HCT, only report therapy administered prior to transformation on the CLL Pre-Infusion Data Form. Any therapy given post-transformation…

Q4-56: Pre-Collection Therapy Given to Enhance Product Collection

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q4-56: Pre-Collection Therapy Given to Enhance Product Collection

Question 4: Was pre-collection chemotherapy given to enhance product collection? Report “Yes” and go to question five if there was pre-collection chemotherapy given to enhance product collection. If “No”, go to question 12. Question 5: Specify where…

Q48-49: Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q48-49: Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)

Veno-occlusvie disease (VOD) / Sinusoidal obstruction syndrome (SOS) occurs following injury to the hepatic venous endothelium, resulting in hepatic venous outflow obstruction due to occlusion of the hepatic venules and sinusoids. This typically results in a…

Q4-26: Disease Assessment at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q4-26: Disease Assessment at the Time of Best Response

Question 4-5: Were tests for molecular markers performed (e.g. PCR)? 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…

Q166-223: Pre-HCT Therapy

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q166-223: Pre-HCT Therapy

The FormsNet3SM application allows questions 167-233 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of lymphoma and prior to the start of the preparative regimen (or prior to infusion if…

Q192-252: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q192-252: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Questions 192-252 refer to the most recent laboratory studies performed prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). “Unknown” should only be reported if there isn’t any documentation or it’s unclear…

Q25-41: Therapy

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q25-41: Therapy

Question 25 : Did the recipient receive any therapy? For the initial form, report “Yes” if the recipient received therapy to treat the respiratory virus infection from 7 days prior to and up to 14 days after the diagnosis date reported in question 1. For the…

Q93-119: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q93-119: Other Laboratory Studies

Questions 93 – 94: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed prior to the start of the preparative regimen / infusion. If hemoglobin electrophoresis studies were performed, report Yes and provide the date…

Q74-100: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q74-100: Other Laboratory Studies

Questions 74 – 75: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed since the date of last report. If hemoglobin electrophoresis studies were performed, report Yes and provide the date of the most recent…

Q38-46: Cell Product Analysis

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q38-46: Cell Product Analysis

*This section applies only to products that are not commercially available. If a commercially available product (e.g., Kymriah® or Yescarta®, TecartusTM, BreyanziTM) or pre-commercial product was selected in question one, continue to question 47. Question 38: Was…

Q151-152: Disease Status at Last Evaluation Prior to the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q151-152: Disease Status at Last Evaluation Prior to the Preparative Regimen

Question 151: What was the disease status at the last evaluation prior to the preparative regimen? Indicate the disease status of WM or LPL at last evaluation prior to the start of the preparative regimen. See WM Response Criteria for disease status…

Q86-92: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q86-92: Disease Modifying Therapies

Question 86: Were disease modifying therapies given? (excludes blood transfusions) Indicate if the recipient received disease modifying therapies (see question 87 for a list of common disease modifying therapies) at any time between diagnosis and the start of the…

Q18-58: Post-HCT Therapy

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q18-58: Post-HCT Therapy

Complete a “Line of Therapy” section for each line of therapy administered during the current reporting period. If multiple lines of therapy were administered, copy and complete questions 19-56 for each line of therapy. Question 18: Was therapy given since the…

Q1-17: Inotuzumab Ozogamicin (Besponsa™)

Infection & Miscellaneous Manuals » 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data » Q1-17: Inotuzumab Ozogamicin (Besponsa™)

Questions 1-2: Did the recipient receive more than one cycle of Inotuzumab Ozogamicin (Besponsa™)? (1 cycle = 3 doses) Indicate “Yes” if more than one cycle (1 cycle = 3 doses) of Inotuzumab Ozogamicin was given. If “Yes” provide the number of cycles in…

Q92-93: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q92-93: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen

Question 92: What was the disease status? Indicate the disease status of JMML at the last evaluation prior to the start of the preparative regimen. If the patient’s disease transformed to AML, do not complete questions 92-93 and continue with the signature…

Q84-185: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q84-185: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 85-185 to be reported multiple times. Complete these questions for each line of therapy administered prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). When submitting…

Q63-64: Transformation

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q63-64: Transformation

Question 63: Did transformation to acute myelogenous leukemia (AML) occur? Indicate if the recipient’s disease transformed to AML between initial diagnosis and the start of the preparative regimen. Approximately 10-15% of JMML cases will transform to AML.…

Q441-615: Organ Function

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q441-615: Organ Function

Links within section: Pulmonary Function Liver Toxicity Prophylaxis Liver Function Thrombotic Microangiopathy Other Organ Impairment / Disorder Pulmonary Function *Bacterial, Viral, and Fungal Pneumonia Report pneumonia due to infection in the Infection section…

Q35-59: Persistence of Cells

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q35-59: Persistence of Cells

!This section pertains to the evaluation of persistence of a cellular product in the recipient and only applies to genetically-modified cellular therapy products. Question 35: Were tests performed to detect persistence of the cellular product since the date of last…

Q17-18: Initial Platelet Recovery

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q17-18: Initial Platelet Recovery

!Initial Platelet Recovery Questions 17-18 can only be completed on the 100 day, 6 month, 1 year, and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods. Optional for Non-U.S. Centers The following questions refer to initial…

Q1-2: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q1-2: Disease Assessment at Diagnosis

Question 1: What is the diagnosis? Waldenström’s macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LPL) are two closely related neoplasms. They are both characterized by an abnormal population of small B-cells, lymphoplasmacytoid cells, and plasma cells. WM is…

Q49-62: Pre-HCT Therapy

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q49-62: Pre-HCT Therapy

!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…

Q67-73: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q67-73: Disease Modifying Therapies

Question 67: Were disease modifying therapies given or stopped since the date of last report? Indicate if the recipient received any disease modifying therapies (see question 68 for a list of common disease modifying therapies) or if the recipient discontinued a…

Q48-94: Disease Detection Since Date of Last Report

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q48-94: Disease Detection Since Date of Last Report

!Questions 48-94 This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 48, 54, 61, 71, and 78, report “No” or “Unknown” (see instructions…

Q142-210: Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q142-210: Post-Infusion Therapy

Question 142: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy prior to relapse as well as therapy given for persistent disease that has not progressed): Indicate…

Q36-86: Disease Relapse or Progression Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q36-86: Disease Relapse or Progression Since the Date of Last Report

Question 36: Did the recipient experience a relapse or progression since the date of the last report? (by any method) Relapse / progression may be detected by imaging assessments (CT, PET, MRI) as well as molecular, cytogenetic, and clinical / hematologic methods.…

Q59-70: Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q59-70: Pre-Infusion Therapy

A single line of therapy refers to any agents administered during the same time period with the same intent. If a recipient’s response changes resulting in a change of treatment, a new line of therapy should be reported. Additionally, if therapy is changed because a…

Q64-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q64-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 64-91 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if no preparative regimen was given. Do not report testing performed during a line of therapy reported in questions 20-68. If testing…

Q1-6: Functional Status

Cellular Therapy Manuals » 3501: Pregnancy Form » Q1-6: Functional Status

!If the female recipient or the male recipient’s female partner is pregnant at the time of submitting this form (created on-demand) or is pregnant on the reported contact date for the current reporting period (created as a result of reporting a pregnancy on the…

Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 69-96 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if not preparative regimen was given. Do not report testing performed during a line of therapy reported in questions 33-68. If testing…

Q192-193: Disease Status at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q192-193: Disease Status at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 192: What was the disease status at the last evaluation prior to the start of the preparative regimen? *Nodular Partial Response Nodular partial response (nPR) is a listed disease status option on the Pre-TED Form (Form 2400), but not on the CLL Pre- and…

Q51-103: Disease Detection Since Date of Last Report

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q51-103: Disease Detection Since Date of Last Report

!Questions 51-103 This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 51, 63, 70, 80, and 87, report “No” or “Unknown” (see instructions…

Q1-20: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q1-20: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

!Post-Infusion Therapy Prior versions of the lymphoma post-infusion manuals have instructed centers to stop tracking the best response to HCT or cellular therapy if the recipient began treatment for persistent disease. The current version of the manual instructs…

Q6-12: Granulopoiesis / Neutrophil Recovery

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q6-12: Granulopoiesis / Neutrophil Recovery

!Questions 6-12 can only be completed on the 100 day, 6 month, 1 year, and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods. Absolute neutrophil recovery (ANC) recovery is defined as an ANC of ≥ 500/mm3 (or ≥ 0.5 ×…

Q26-42: Hematologic Findings at Diagnosis of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q26-42: Hematologic Findings at Diagnosis of Infection

Question 26-36: Complete Blood Count Report the date of the complete blood count (CBC) performed closest to the date of diagnosis of the fungal infection being reported on this form. The CBC must have been performed within seven days of the date of diagnosis.. For…

Q253-256: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q253-256: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Questions 253-256 refer to the most recent assessments performed prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). Question 253: What was the disease status? Indicate the disease status using the international…

Q43-98: Therapy

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q43-98: Therapy

Treatment for VOD/SOS is generally intended to normalize flow through the hepatic vessels by resolving the central venous and sinusoidal obstruction and preventing fibrosis. Supportive therapies such as hypertransfusions may also be started to improve renal and…

Q32-68: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q32-68: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 33-68 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of AML and prior to the start of the preparative regimen (or prior to infusion if no…

Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Question 1: Compared to the disease status prior to the preparative regimen, what was the best response to HCT or cellular therapy since the date of the last report? (Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any…

Q20-63: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q20-63: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 28-63 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of ALL and prior to the start of the preparative regimen (or prior to infusion if no…

Q51-76: Therapy

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q51-76: Therapy

Question 51: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of contact for this reporting period? Report “Yes” if the recipient received any antiviral medication between seven days prior to the date of…

Q11-24: Hematologic Findings at Diagnosis of Infection

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q11-24: Hematologic Findings at Diagnosis of Infection

Question 11-21: Complete Blood Count For the initial form, report the date and values of the complete blood count (CBC) performed closest to the date of diagnosis, within seven days of the date of diagnosis of the respiratory viral infection being reported on this…

Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen

Question 48: Were central nervous system (CNS) abnormalities found on computed topography (CT or CAT) or magnetic resonance imaging (MRI) scans? Indicate if radiology (CT, CAT, and/or MRI) performed on the recipient between diagnosis and the start of the preparative…

Q108-130: Engraftment Syndrome

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q108-130: Engraftment Syndrome

!Questions 108-130 can only be completed on the 100 day follow-up form. These questions will be skipped for all subsequent reporting periods. Question 108-109: Did engraftment syndrome occur? Engraftment syndrome typically occurs during neutrophil recovery post-HCT…

Q640-664: Functional Status

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q640-664: Functional Status

!Questions 640-644 will only be answered on the day 100 Form. Centers will not be able to complete these questions for any subsequent reporting periods. Question 640: Was the intent to complete HCT procedure (conditioning, infusion, and period of recovery from…

Q21-35: Post-HCT or Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q21-35: Post-HCT or Post-Infusion Therapy

!Post-Infusion Therapy Prior versions of the lymphoma post-infusion manuals have instructed centers to report treatment for persistent disease in the same data fields as treatment for relapse / progression. The current version of the manual instructs centers to report…

Q428-440: Infection

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q428-440: Infection

Infections occur frequently in transplant patients. Questions 428-440 are intended to capture detailed information on clinically significant infections diagnosed during the reporting period. A single infection may be found on multiple cultures or at multiple sites.…

Q6-18: Transfusion Therapy

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q6-18: Transfusion Therapy

Question 6: Were any red blood cell (RBC) transfusions administered? Red blood cell (RBC) transfusions are often given as supportive care to lower hemoglobin S for recipients diagnosed with Sickle Cell Disease (SCD). If the recipient received any RBC transfusions…

Q665-672: Subsequent HCT

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q665-672: Subsequent HCT

*Subsequent Transplant Complete this section if the recipient received a subsequent HCT (question 3, answered “yes”). In addition to this section, a new Pre-TED Form (Form 2400) and Recipient Baseline Data Form (Form 2000) must be completed for the subsequent HCT.…

Q157-187: Pre-HCT Therapy

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q157-187: Pre-HCT Therapy

!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…

Getting Started

Getting Started » 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…

Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 149: Did the recipient have known nodal involvement? Refer to Graphic 1 for identification of nodal areas. Nodal involvement may be assessed by a physician palpating lymph nodes, pathology from a lymph node biopsy, or radiological assessment (e.g., PET or CT…

Q43-49: Treatment of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q43-49: Treatment of Infection

Question 43: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of contact for this reporting period? Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of…

Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 234-288 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if not preparative regimen was given). Do not report testing performed during a line of therapy reported in questions 167-223. If…

Q80-170: Toxicities

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q80-170: Toxicities

*Report any observed toxicity or infection that occurs post-infusion in this reporting period, regardless of causality and whether or not treatment was administered. The intent is to capture all toxicities diagnosed after the cellular therapy infusion. Although…

Q26-31: Treatment of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data » Q26-31: Treatment of Infection

Question 26: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of infusion? Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of diagnosis (refer to question…

2565: Sanofi Mozobil Supplemental Data

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data

The Sanofi Mozobil Supplemental Data Collection Form (Form 2656) is designed to support a prospective, multicenter, observational registry of myeloma recipients undergoing hematopoietic progenitor cell mobilization and peripheral blood stem cell collection for upfront…

Q164-167: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q164-167: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

Questions 164-165: Specify other acute leukemia classification Indicate the other acute leukemia disease classification at diagnosis. If the subtype is not listed, report as “other leukemia” and specify the reported disease. Acute undifferentiated leukemia is a…

Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy

Question 78: Was lymphodepleting therapy given prior to the infusion? (does not include lines of therapy given for disease treatment, bridging therapy, or maintenance) Lymphodepleting therapy is given to destroy lymphocytes and T cells. Indicate Yes or No if the…

Q3-12: Cell Product Source

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q3-12: Cell Product Source

Question 3-4: Date of cell product collection Report if the date of cell product collection is Known or Unknown. If the date of cell product collection is Known, report the date (YYYY-MM-DD). If the date of cell product collection is Unknown, continue with question…

Q18-32: Cellular Therapy and HCT History

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q18-32: Cellular Therapy and HCT History

Question 18: Is this the first time the recipient is being treated using a cellular therapy (non-HCT)? This is defined as the first application of a cellular therapy the recipient ever receives, not the first application the recipient receives at your facility. The…

Q1-23: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Cellular Therapy Manuals » 3500: Subsequent Neoplasms » Q1-23: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

*The submission of a pathology report or other supportive documentation for each reported new malignancy is strongly recommended. Questions 1-3: Specify the new malignancy: Indicate which new malignancy / disorder was diagnosed during the reporting period. If the new…

Q12-20: Peripheral Blood Count Recovery

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q12-20: Peripheral Blood Count Recovery

!Questions 12 – 15 can only be completed on the 100 day and 6 month follow-up forms. These questions will be disabled for all subsequent reporting periods. Combined follow up In scenarios where an HCT was given after a cellular therapy and this form is now being…

Q73-87: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q73-87: Post-HCT / Post-Infusion Therapy

Question 73: Was therapy given since the date of last report for reasons other than relapse or persistent disease? (include any maintenance therapy) Indicate if the recipient received treatment post-infusion for reasons other than relapse or persistent disease during…

Q1-21: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q1-21: Disease Assessment at Diagnosis

*Subsequent Infusion If this is a report of a second or subsequent transplant or cellular therapy, check “yes” under the Subsequent Transplant or Cellular Therapy section of the form and continue with question 149. Questions 1-2: What was the date of diagnosis of…

Q1-13: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q1-13: Disease Assessment at Diagnosis

Question 1: Is the disease (AML) therapy related? (not MDS / MPN) Agents such as radiation or systemic therapy used to treat other diseases (e.g., Hodgkin lymphoma, non-Hodgkin lymphoma, and breast cancer) can damage the marrow and lead to a secondary malignancy such…