2025 Manual Updates

December 2025
October 2025
July 2025
April 2025
March 2025
February 2024
January 2025

Updates made during the current calendar year are included below. For updates prior to 2023, click on the subtopic corresponding to the year of interest. If you need to reference an archived manual section for a retired form, please refer to the Retired Forms Manuals webpage.

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December 2025

12/12/2025	2126: Neuroblastoma Post-Infusion	Add	Version 2 of the Neuroblastoma Post-Infusion section of the Forms Instructions Manual released. Version 2 corresponds to revision 3 of the Form 2126.
12/12/2025	2026: Neuroblastoma Pre-Infusion	Modify	Version 2 of the Neuroblastoma Pre-Infusion section of the Forms Instruction Manual released. Version 2 corresponds to revision 3 of the Form 2026.
12/12/2025	2018: LYM Pre-Infusion	Modify	Version 6 of the 2018: Lymphoma Pre-Infusion Data section of the Forms Instruction Manual released. Version 6 corresponds to revision 7 of the Form 2018.

October 2025

10/24/2025	3500: Subsequent Neoplasms	Modify	Version 3 of the 3500: Subsequent Neoplasms section of the Forms Instructions Manual released. Version 3 corresponds to revision 3 of the Form 3500.
10/24/2025	2450: Post-TED	Modify	Version 8 of the 2450: Post-TED section of the Forms Instruction Manual released. Version 8 corresponds to revision 9 of the Form 2450.
10/24/2025	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Version 6 of the 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion section of the Forms Instruction Manual released. Version 6 corresponds to revision 7 of the Form 2006.
10/24/2025	4100: Cellular Therapy Essential Data Follow-Up	Add	Q82 – 83 updated: Check all that apply from the list of drug(s) given to treat neurotoxicity in this reporting period. Pulse dose of corticosteroids are intravenous (IV) high doses given intermittently over a short time period. Specify if Other therapy is selected. Supportive care treatments should not be reported as treatment for neurotoxicity. Examples of what not to report as other therapy include, but are not limited to, antibiotics (e.g., amoxicillin, cefepime, ciprofloxacin, piperacillin), antipsychotics (e.g., Risperdal) narcotics/opioids, or other pain killers. If a drug was started as planned prophylaxis but the recipient develops neurotoxicity and the drug is continued, this is considered a change in intent from prophylaxis to treatment and the drug should also be reported as therapy for neurotoxicity.
10/24/2025	4100: Cellular Therapy Essential Data Follow-Up	Add	Q50 – 52 updated: If Tocilizumab was given to treat the CRS, report the number of doses given. This information is important in the grading of the CRS event. If a drug was started as planned prophylaxis but the recipient develops CRS and the drug is continued, this is considered a change in intent from prophylaxis to treatment and the drug should also be reported as therapy for CRS.
10/24/2025	4100: Cellular Therapy Essential Data Follow-Up	Modify	GVHD treatment CR criteria updated in table 1 in Q12: Improvement but not resolution of symptoms, or remains on immune suppression Resolution of symptoms and off immune suppression
10/24/2025	4100: Cellular Therapy Essential Data Follow-Up	Add	Table 2 added in Q13
10/24/2025	Multiple Myeloma Response Criteria	Add	Clarified definition of renal failure in Free Light Chain Ratios blue box: Free Light Chain Ratios: For recipients with renal failure (serum creatinine > 2 mg / dL), the normal kappa / lambda ratio range is 0.37 – 3.1; any value within this range should be considered within normal limits. Note, this is a broader range than the normal kappa / lambda ratio range of 0.26 – 1.65 that is used to determine disease status for recipients without renal failure.
10/24/2025	Multiple Myeloma Response Criteria	Add	Additional information added to sCR criteria: Follows criteria for CR as defined below, plus all of the following: Normal free light chain ratio, See blue box above regarding Free Light Chain Ratios Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence (confirmation with repeat bone marrow biopsy not needed). (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells) Alternatively, the absence of clonal plasma cells can be defined based on the investigation of phenotypically aberrant plasma cells. The sensitivity level is 10-3 (less than one phenotypically aberrant plasma cell within a total of 1000 plasma cells)
10/24/2025	Appendix D: How to Distinguish Infusion Types	Modify	Table 1.Distinguishing Infusion Types updated
10/24/2025	2028: Aplastic Anemia Pre-Infusion	Add	Blue instruction box added on how to report transfusions for subsequent infusions: Subsequent Infusions and Transfusions: If this is a subsequent infusion and the 2028 was completed for the previous infusion, report the number of transfusions the recipient received for aplastic anemia between Day 0 of the previous infusion and the start of the preparative regimen for the current infusion.
10/24/2025	2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion	Add	Clarified how to report the MF grade when documented as a range in Q32 and 232: Specify the Myelofibrosis grading using the WHO classification. The classification and results should be clarified in the pathology report as dictated by the pathologist. If the grade is provided as a range (i.e., MF 2 – 3), report the highest of the two grades.
10/24/2025	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Clarified how to report the MF grade when documented as a range in Q78, 172, 267:Clarified how to report the MF grade when documented as a range: Specify the Myelofibrosis grading using the WHO classification. The classification and results should be clarified in the pathology report as dictated by the pathologist. If the grade is provided as a range, (i.e., MF 2 – 3), report the highest of the two grades.
10/24/2025	2555: MF Eligibility	Add	Clarified why CRF data is required: 6. Submit Comprehensive Report Forms for all myelofibrosis recipients regardless of age at transplant. MF data has high research value and it is critical to have CRF data for this study.
10/24/2025	2100:Post-Infusion Follow-Up Form	Modify	Red warning box explaining with chimerism section comes due above Q57 updated: For non-malignant disease, the Chimerism Studies section can only be completed on the 100 day, 6 month, and 1 year follow-up forms. For malignant disease, the Chimerism Studies section can only be completed on the 100 day and 1 year follow-up forms. These questions will be skipped for all subsequent reporting periods.
10/24/2025	2451: Chimerism Essential Data	Add	Instructions added on how to report multiple other cell types in Q2 : If multiple ‘other’ cell types were assessed and are being reported, add an additional instance in the FormsNet3SM application.
10/24/2025	2402: Disease Classification	Modify	Version 10 of the 2402: Pre-TED Disease Classification section of the Forms Instructions Manual released. Version 10 corresponds to revision 10 of the Form 2402.
10/24/2025	2199: Donor Lymphocyte Infusion	Modify	Version 2 of the 2199: Donor Lymphocyte Infusion section of the Forms Instruction Manual released. Version 2 corresponds to revision 2 of the Form 2199.
10/24/2025	2814: Indication for CIBMTR Data Reporting	Add	MIBG blue box added above Q4: Infusion for Low Blood Counts Following MIBG Therapy: An infusion given as a ‘rescue’ for low blood counts following MIBG therapy is not reported as a HCT. Refer to the 2026: Neuroblastoma Pre-Infusion Manual for more information.
10/24/2025	2814: Indication for CIBMTR Data Reporting	Modify	Instructions updated when an allogeneic infusion is considered a new transplant or an allogeneic boost, dependent upon the indication: Graft failure: Additional stem cells are required because the ANC did not recover following HCT (primary graft failure), or hematopoietic recovery indefinitely declined after the initial hematopoietic recovery or hematopoietic recovery (secondary graft failure) Autologous infusion: If autologous cells are infused for this reason, this is considered an autologous rescue; in this case, reporting will continue under the prior HCT date, and a new Pre-TED form is not required. Allogeneic infusion: If allogeneic cells are infused, regardless of whether a new allogeneic donor or a prior allogeneic donor is used, this is considered a subsequent HCT. A new Pre-TED is required, and a new set of follow-up forms will come due, as applicable. Poor graft function / insufficient donor chimerism: Additional stem cells are required because hematopoietic recovery was deemed insufficient or too slow for survival following previous high-dose therapy and HCT. Autologous infusion: If autologous cells are infused for this reason, this is considered an autologous rescue. Reporting will continue under the prior HCT date, and a new Pre-TED form is not required. If allogeneic cells are infused, this would be considered a subsequent HCT, and a new Pre-TED is required, and a new set of follow up forms will come due, as applicable. Allogeneic infusion using a prior allogeneic donor: If allogeneic cells from a prior donor are infused, this is considered an allogeneic boost. Reporting will continue under the prior HCT date, and the Donor Cellular Infusion (2199) Form is required. Allogeneic infusion using a new allogeneic donor: If allogeneic cells are infused using a new allogeneic donor, this is considered a subsequent HCT. A new Pre-TED is required, and a new set of follow-up forms will come due, as applicable. In the case of a stable, mixed donor chimerism, the infusion of additional cells (usually lymphocytes and not mobilized stem cells) is typically classified as a DCI. Verify with the transplant physician that the cells given should be reported as a subsequent transplant and that stable, mixed chimerism is the reason for the transplant. However, in the case of declining chimerism – when the percentage of donor cells is sequentially decreasing on several studies, indicating possible impending graft failure – additional stem cells are required. Usually, the donor chimerism has fallen below 30-50%.
10/24/2025	2451: Chimerism Essential Data	Add	Reporting Results for Multiple Donors blue box added to the chimerism results section: Reporting Results for Multiple Donors: When there are multiple donors (either from a prior infusion or the current infusion), chimerism results must be entered for every cell type assessed, for each donor, even if the results are ‘0.’.
10/24/2025	2807: Race, Ethnicity and Ancestry	Add	Version 1 of the 2807: Race, Ethnicity and Ancestry section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 2807.
10/24/2025	2005: Confirmation of HLA Typing	Modify	Version 6 of the 2005: Confirmation of HLA Typing section of the Forms Instruction Manual released. Version 6 corresponds to revision 8 of the Form 2005.
10/24/2025	2004: Infectious Disease Markers	Modify	Version 6 of the 2004: Infectious Disease Markers section of the Forms Instruction Manual released. Version 6 corresponds to revision 6 of the Form 2004.
10/24/2025	2451: Chimerism Essential Data	Add	Clarified when the 2451 comes due for recipients with malignant diseases on the CRF track: Recipients who receive an allogeneic transplant using cord blood units Allogeneic recipients whose primary disease for infusion is non-malignant Allogeneic recipients whose primary disease for infusion is malignant The Chimerism Essential Data (2451) will only come due if chimerism studies were reported on the Day 100 and 1 Year Post-Infusion Follow-Up (2100) Form
10/24/2025	2126: Neuroblastoma Post-Infusion	Add	Updated Neuroblastoma Response Criteria blue box added to Q179, 213, and 249: Updated Neuroblastoma Response Criteria With the Fall 2025 quarterly release, the Neuroblastoma Response Criteria in the CIBMTR Forms Instruction Manual was updated to be consistent with the current International Neuroblastoma Response Criteria; however, the response options available on the Neuroblastoma Pre- and Post-Infusion (2026 / 2126) Forms have not yet been updated. Refer to Table 2. Neuroblastoma Disease Status Response Options provided in the updated Neuroblastoma Response Criteria to determine which response option should be reported. The response options available on the Neuroblastoma Pre- and Post-Infusion (2026 / 2126) Forms will be updated when the forms are next revised.
10/24/2025	2026: Neuroblastoma Pre-Infusion	Add	Updated Neuroblastoma Response Criteria blue box added to Q179, 213, and 249: Updated Neuroblastoma Response Criteria With the Fall 2025 quarterly release, the Neuroblastoma Response Criteria in the CIBMTR Forms Instruction Manual was updated to be consistent with the current International Neuroblastoma Response Criteria; however, the response options available on the Neuroblastoma Pre- and Post-Infusion (2026 / 2126) Forms have not yet been updated. Refer to Table 2. Neuroblastoma Disease Status Response Options provided in the updated Neuroblastoma Response Criteria to determine which response option should be reported. The response options available on the Neuroblastoma Pre- and Post-Infusion (2026 / 2126) Forms will be updated when the forms are next revised.
10/24/2025	Neuroblastoma Response Criteria	Modify	Version 2 of the Neuroblastoma Response Criteria section of the Forms Instructions Manual released.
10/24/2025	2400: Pre-TED	Modify	Version 10 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 10 corresponds to revision 11 of the Form 2400.
10/24/2025	2900: Recipient Death	Modify	Version 5 of the 2900: Recipient Death section of the Forms Instructions Manual released. Version 5 corresponds to revision 6 of the Form 2900.
10/24/2025	Appendix I: Race, Ethnicity and Ancestry	Add	Version 2 of Appendix I: Race, Ethnicity and Ancestry (REA) released with the Fall 2025 Quarterly release

July 2025

7/25/2025	2402: Disease Classification	Remove	Diagnostic criteria for plasmacytoma updated in PCD section: Plasmacytoma (in absence of bone marrow findings diagnostic for multiple myeloma or plasma cell leukemia) Extraosseous plasmacytoma No M-protein in serum and/or urine Extramedullary tumor of clonal plasma cells Normal bone marrow Normal skeletal survey No related organ or tissue impairment (end organ damage including bone lesions) Solitary plasmacytoma of bone No M-protein in serum and/or urine Single area of bone destruction due to clonal plasma cells Bone marrow not consistent with multiple myeloma Normal skeletal survey (and MRI of spine and pelvis if done) No related organ or tissue impairment (no end organ damage other than solitary bone lesion)5
7/25/2025	2402: Disease Classification	Add	Clarified which method to use when reporting BM blasts in Q250: Indicate whether the percentage of blasts in the bone marrow was Known or Unknown at the last evaluation prior to the start of the preparative regimen / infusion. If Known, report the percentage documented on the pathology report. If multiple assessments were performed at the last evaluation, report the most recent assessment prior to the start of the preparative regimen / infusion. If multiple methods were used to detect the percentage of blasts in the bone marrow, the aspirate differential is the preferred method; followed by flow cytometry and IHC (immunohistochemical staining).
7/25/2025	2400: Pre-TED	Add	Recipient Research Repository Consent and Prior Infusion blue box added in Q12: Recipient Research Repository Consent and Prior Infusions: The recipient consent to the Research Repository question should only be answered for the recipient’s first allogeneic transplant. If the recipient has had prior autologous or cellular therapy infusions, and this infusion is the first allogeneic, please override the error message. If the recipient has had prior allogeneic infusion(s), please leave this question blank.
7/25/2025	2451: Chimerism Essential Data	Add	Version 1 of the 2451: Chimerism Essential Data section of the Forms Instructions Manual released. Version 1 corresponds to revision 3 of the Form 2451.
7/25/2025	2100:Post-Infusion Follow-Up Form	Add	Reporting Chimerism Results and the Chimerism Essential Data (2451) red warning box added above Q57: Reporting Chimerism Results and the Chimerism Essential Data (2451): If completing this form after July 25, 2025, and chimerism studies were performed in the reporting period, report Yes, chimerism studies were performed post-infusion below and the Chimerism Essential Data (2451) will come due to report the results. For forms completed prior to July 25, 2025, the Chimerism Essential Data (2451) did not come due and the chimerism results are reported on this form below
7/25/2025	2100:Post-Infusion Follow-Up Form	Modify	Updated red warning box above Q57 clarifying when chimerism section is enabled: The Chimerism Studies section can only be completed on the 100 day, 6 month, and 1 year , and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods.
7/25/2025	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Modify	Clarified how to report relapse in Q155: 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. Report ‘Yes’ if the relapse criteria were met, or transformation from AML occurred (see red box below) after starting this line of therapy and prior to starting the subsequent line of therapy.
7/25/2025	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Modify	Clarified how to report the relapse date in Q156: Enter the date of the assessment that established relapse following the after starting this line of therapy. Report the date of the pathological evaluation (e.g., bone marrow) or blood/serum assessment (e.g., CBC, peripheral blood smear). Enter the date the sample was collected for pathological and laboratory evaluations. If extramedullary disease is detected upon radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), enter the date the imaging took place. If the physician determines cytogenetic or molecular relapse, enter the date of sample collection for cytogenetic or molecular evaluation. If the physician determines evidence of relapse following a clinical examination during an office visit, report the date of assessment. 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.
7/25/2025	2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion	Modify	Clarified how to report relapse / progression in Q211: Refer to the MPN Response Criteria section when determining the recipient’s disease status. Indicate if the disease relapsed from CR or progressed. If the disease relapsed or progressed, answer “Yes” and go to question 212. If “No,” go to question 213. Report ‘Yes’ if the relapse or progression criteria was met after starting this line of therapy and prior to starting the subsequent line of therapy.
7/25/2025	2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion	Modify	Clarified how to report the relapse / progression date in Q212: Enter the date of the assessment that established relapse or progression following the after starting this line of therapy. Enter the date the sample was collected for pathological and laboratory evaluations. If extramedullary disease is detected upon radiographic examination (e.g., X ray, CT scan, MRI scan, PET scan), enter the date the imaging took place. If the physician determines cytogenetic or molecular relapse, enter the date of sample collection for cytogenetic or molecular evaluation. If the physician determines evidence of relapse following a clinical examination during an office visit, report the date of assessment. 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.
7/25/2025	Appendix C: Chimerism and Cytogenetics	Add	Add SNP row to Table 1. Chimerism Methods
7/25/2025	2400: Pre-TED	Modify	Instruction updated on how to answer Q135 – 139 when peri-transplant drugs were not given: For each agent listed, indicate whether the drug was administered during the peri-transplant period to prevent transplant-related complications or facilitate engraftment, and any additional question(s) for each drug administered. ALG (Anti-Lymphocyte Globulin), ALS (Anti-Lymphocyte Serum), ATG (Anti-Thymocyte Globulin, ATS (Anti-Thymocyte Serum): Serum or gamma globulin preparations containing polyclonal immunoglobulins directed against lymphocytes. These drugs are usually prepared from animals immunized against human lymphocytes. Report the total dose prescribed pre and post infusion and the animal source. If Other is selected, specify the source. Alemtuzumab (Campath): Antibody preparations that are infused in the recipient. Report the total dose prescribed pre and postinfusion to the nearest tenth and specify the units of measurement. Defibrotide: Antithrombotic agent used to prevent veno occlusive disease. KGF (keratinocyte growth factor): Alternate names: palifermin, Kepivance. KGF acts to stimulate the growth of cells that line the surface of the mouth and intestinal tract. KGF may also be given to treat oral mucositis or as GVHD prophylaxis. Ursodiol: A naturally occurring bile acid used to dissolve small gall stones and to increase bile flow in patients with primary biliary cirrhosis. If the recipient did not receive any of the drugs listed above, leave these questions blank and override the error as ‘verified correct’ select None.
7/25/2025	2400: Pre-TED	Add	Instructions updated in Q71: Indicate if the related donor signed an IRB-approved consent form to donate research blood samples to the CIBMTR. This question should only be answered if this is the recipient’s first allogeneic transplant.
7/25/2025	2400: Pre-TED	Add	Instructions updated in Q73: There are a select number of transplant centers participating in the Related Sample Repository. If your center is one of the participating centers, and the donor provided a research sample, select Yes and provide the donor’s sample ID for the current infusion. The ID number is located on the bar code that is attached to the sample tube. If the donor did not provide a research sample, select No.
7/25/2025	2400: Pre-TED	Add	Instructions updated in Q14: There are a select number of transplant center participating in the Related Specimen Repository. If your center is one of the participating centers, and the recipient provided a research sample, select Yes and provide the recipient’s sample ID in Research sample recipient ID for the current infusion. The ID number is located on the bar code that is attached to the sample tube.
7/25/2025	2400: Pre-TED	Add	Instructions updated on when Q12 comes due for subsequent transplants: The Research Sample Repository contains blood samples from unrelated recipients and/or their adult volunteer donors or cord blood units. Related allogeneic recipients and/or donors will participate at selected transplant centers. The primary objective of the Research Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cellular transplantation. Studies in which these data may be used include Improving the understanding of tissue matching for hematopoietic cellular donors and recipients. Determining and evaluating the factors that affect transplant outcomes. Studying the distribution of HLA tissue types in different populations (e.g., study tissue typing differences between different racial and ethnic populations to help develop methods to improve tissue matching between donors and recipients, including testing of rare HLA types). Indicate if the recipient signed an IRB-approved consent form to donate research blood samples to the NMDP / CIBMTR. If Yes (recipient consented), continue with _Date form signed. If No (recipient declined), Not approached, or Not applicable (center not participating), continue with Is the recipient participating in a clinical trial. For subsequent allogeneic transplants, this question is disabled, and blood samples are not submitted as consent and blood sample collection is only required for the first allogeneic transplant.

April 2025

4/30/2025	4100: Cellular Therapy Essential Data Follow-Up	Add	Added new warning box above question 47: Effective April 30th, 2025, report only toxicities (e.g. CRS, neurotoxicity, etc.) that are directly attributed to the CAR-T product / infusion. It is no longer required to report any toxicity regardless of causality. Treatment given post-infusion may have the effect of re-activating the product and inducing toxicities (e.g. CRS), these toxicities should NOT be captured in this section of the form. Contact CIBMTR Center Support with questions.
4/30/2025	4100: Cellular Therapy Essential Data Follow-Up	Remove	Removed the blue note box above question 47: 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 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.
4/19/2025	2013: CLL Pre-Infusion	Add	Disease Assessment at the Last Evaluation and CLL to NHL Transformations blue note box added to Q105: Disease Assessments at the Last Evaluation and CLL to NHL Transformations: When CLL has transformed to NHL, the disease assessment at the last evaluation section will be disabled.
4/19/2025	3501: Pregnancy Form	Add	Version 2 of the 3501 Pregnancy Form section of the Forms Instructions Manual released. Version 2 corresponds to revision 3 of the Form 3501.
4/19/2025	2400: Pre-TED	Add	Gene therapy examples 6 and 7 added to Q75: Example 6 (single product): a single mobilization event, even when collected over several days Example 7 (single product): A recipient may require multiple mobilizations, and possibly multiple manufacturing steps, for the final product intended for infusion. It should be considered a single gene therapy product, regardless of how many mobilizations or steps required for manufacturing.
4/19/25	Q12-14: Best Response to Cellular Therapy	Add	Added blue box above question 13: If a subsequent cellular therapy was given for disease relapse / progression and the F4000 was made NRQ, the best response prior to the relapse/ progression should be reported.
4/19/2025	MDS Post-HCT	Modify	Correct typo in Q229: Indicate if the recipient’s disease status was assessed by any other assessment at the time of evaluation for this reporting period. Indicate “yes” if the disease status was assessed by other assessment at the time of evaluation for this reporting period, report the date of assessment in question 230, and specify the name of the other assessment in question 231. Indicate “no” if the disease status was not assessed by other assessment at the time of best response evaluation for this reporting period and continue with question 233.
4/19/2025	2013: CLL Pre-Infusion	Modify	Clarification: Systemic symptoms or B symptoms (also known as constitutional symptoms) include unexplained fever > 38˚ C (100.4˚ F), night sweats, and / or unexplained weight loss of >10% of body weight in six months before treatment diagnosis. Specify if the recipient had B symptoms within six months prior to the diagnosis. If it is unclear if symptoms were present within six months prior to the diagnosis, seek physician clarification.
4/19/2025	2100:Post-Infusion Follow-Up Form	Add	Instructions clarified when to report Yes or No for coronary artery disease: Indicate if the recipient experienced a cardiac impairment or disorder. Review the list below to determine if the condition should be reported as cardiac impairment / disorder. Refer to Table 5. Cardiac Impairments for an overview of when to report the impairment. If Yes, report the onset date, specify if the impairment / disorder, and answer any other applicable questions. If the cardiac impairment or disorder is an arrhythmia, cardiomyopathy, unstable angina, hypertension requiring treatment, pericarditis, coronary artery disease (CAD), or heart valve disease, use the following guidelines to determine when to report Yes or No:
4/19/2025	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Correct typo in Q272: Indicate if the recipient’s disease status was assessed by any other assessment at the time of evaluation for this reporting period. Indicate “yes” if the disease status was assessed by other assessment at the time of evaluation for this reporting period, report the date of assessment in question 273, and specify the name of the other assessment in question 274. Indicate “no” if the disease status was not assessed by other assessment at the time of best response evaluation for this reporting period and continue with question 276.
4/19/2025	Reporting Instructions Overview: Contact Dates – Subsequent Infusions and Contact Dates	Add	Example 4 added: The recipient had a subsequent auto transplant for graft failure and death occurred in the same reporting period. The recipient has their first transplant on 3/1/2023 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/2023 and death occurred on 5/20/2023. Report the Day 100 contact date as the date of death, 5/20/2023.
4/19/2025	Reporting Instructions Overview: Contact Dates – Subsequent Infusions and Contact Dates	Add	Subsequent Cell Therapy and Death blue box added: Subsequent Cell Therapy and Death: For a subsequent cellular therapy, if the Cellular Therapy Essential Data Pre-Infusion (4000) is requested via CIBMTR Center Support to be made “NRQ”, the death and subsequent infusion can be reported on the same form.
4/19/2025	Reporting Instructions Overview: Contact Dates – Subsequent Infusions and Contact Dates	Add	Example 9 added: The recipient had a subsequent non-genetically modified cellular therapy and death occurred in the same reporting period. The recipient has their first transplant on 1/21/23 and a non-genetically modified cellular therapy infusion on 2/15/23. Death occurred on 3/1/23. Report the Day 100 contact date as the date of death, 3/1/23
4/19/2025	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Add	ET or PCV to MDS Transformation and Disease Assessments at Diagnosis blue note box added above Q2: ET or PCV to MDS Transformation and Disease Assessments at Diagnosis: If MDS transformed from ET or PCV, report assessments from the time of the MDS transformation. Do not report assessments from the time of ET or PCV diagnosis.
4/19/2025	2402: Disease Classification	Add	ET or PCV to MDS Transformation and Disease Assessments at Diagnosis blue note box added above Q201: ET or PCV to MDS Transformation and Disease Assessments at Diagnosis: If MDS transformed from ET or PCV, report assessments from the time of the MDS transformation. Do not report assessments from the time of ET or PCV diagnosis.

March 2025

3/6/2025	2037: Leukodystrophies Post-Infusion	Add	New blue note box above question 45: Neurocognitive Assessment (3503) Form: The Neurocognitive Assessment Form will only come due for recipients enrolled in CIBMTR study CS20-51 when a neurocognitive test was administered.
3/6/2025	2137: Leukodystrophies Post-Infusion	Add	New blue note box above question 45: Neurocognitive Assessment (3503) Form: The Neurocognitive Assessment Form will only come due for recipients enrolled in CIBMTR study CS20-51 when a neurocognitive test was administered.

February 2025

2/20/2025	3505: Transfusion	Add	New blue note box above question 1: Zyntelgo®, For the 100d follow up form, include the last RBC transfusion given prior to discharge from the hospital post-infusion.
2/20/2025	3505: Transfusion	Add	New blue note box above question 6: Zyntelgo®, Report only the first and last platelet transfusion in the reporting period.

January 2025

1/28/2025	2814: Indication for CIBMTR Data Reporting	Modify	Added new floating text to the non-cellular therapy option: Indicate whether the individual will be receiving an Infusion (e.g., hematopoietic cellular transplant (HCT), gene therapy, cellular therapy), Marrow toxic injury, or Non-cellular therapy (e.g., study enrollment, chemotherapy, immunotherapy, etc.).
1/28/2025	2814: Indication for CIBMTR Data Reporting	Remove	Removed the red warning box: Non-cellular Therapy: There are currently no active studies for this option. If this seems to be incorrect, submit a CIBMTR Center Support ticket
1/28/2025	2814: Indication for CIBMTR Data Reporting	Add	New blue note box added: CMS Innovation Center’s Cell and Gene Therapy (CGT) Access Model for Sickle Cell Disease (SCD) Select “non-cellular therapy” when completing this form for the first time for a CRID to be enrolled in the CMS Innovation Center’s Cell and Gene Therapy (CGT) Access Model for Sickle Cell Disease (SCD). Contact CIBMTR Center Support with any questions.
1/24/2025	3507: Solid Tumor Response	Add	Version 1 of the Solid Tumor Response section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 3507.
1/24/2025	2059 Solid Tumor Pre-Infusion	Add	Version 1 of the Solid Tumor Pre-Infusion section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 2059.
1/24/2025	2554: CMS Registration	Add	Version 1 of the CMS Registration section of the Forms Instructions Manual released. Version 1 corresponds to revision 3 of the Form 2554.
1/24/2025	2402: Disease Classification	Remove	Instructions in Q180 updated: CIBMTR captures the classification of ambiguous lineage and other myeloid neoplasms based on the World Health Organization (WHO) 2022. Indicate the other acute leukemia disease classification at diagnosis. If the subtype is not listed, report as Other acute leukemia of ambiguous lineage or myeloid neoplasm and specify the reported disease. Acute undifferentiated leukemia is a type of AML characterized by immature predominating cells that cannot be classified. Biphenotypic, bilineage, or hybrid leukemias have characteristics representative of both myeloid and lymphoid lineages. Mast cell leukemia is characterized by an increased number of tissue mast cells in the peripheral blood.
1/24/2025	2402: Disease Classification	Add	Myelodysplastic/myeloproliferative neoplasm with neutrophilia and Disease Status added above Q195 and Q390: Myelodysplastic/myeloproliferative neoplasm with neutrophilia and Disease Status: As of October 2024, atypical CML is captured as an MDS and the disease classification is reported as Myelodysplastic/myeloproliferative neoplasm with neutrophilia. The disease status for Myelodysplastic/myeloproliferative neoplasm with neutrophilia will be reported in the Other Leukemia section of the form.
1/24/2025	ALL Response Criteria	Add	Relapse Criteria blue box added for clarification: Relapse Criteria: The Disease presence determined by a physician upon clinical assessment criteria is not if there is only disease detected by MRD or other methods of assessment (i.e., molecular, cytogenetics, flow cytometry). In order to report relapse, disease must be detected by clinical / hematologic assessments.
1/24/2025	AML Response Criteria	Add	Relapse Criteria blue box added for clarification: Relapse Criteria: The Disease presence determined by a physician upon clinical assessment criteria is not if there is only disease detected by MRD or other methods of assessment (i.e., molecular, cytogenetics, flow cytometry). In order to report relapse, disease must be detected by clinical / hematologic assessments.
1/24/2025	2130 SCD Post-Infusion	Modify	Abdominal Girth red warning box above Q2 updated: p(banner important). Abdominal girth and Blood Pressure: Abdominal girth and blood pressure are is currently disabled and cannot be answered at this time.
1/24/2025	2100:Post-Infusion Follow-Up Form	Remove	Instructions in Q48 updated: Lymphocyte analyses are often performed post-HCT to evaluate the reconstitution of the immune system. Certain lymphocyte groups repopulate earlier than others post-HCT. If lymphocyte testing was performed, select all lymphocytes tested during the reporting period and answer the subsequent questions as follows. CD3 (T cells) CD4 (T helper cells) CD8 (cytotoxic T cells) CD19 (B lymphocyte cells) CD20 (B lymphocyte cells) CD56 (natural killer (NK) cells) If lymphocyte testing was not completed during the reporting period, select No lymphocyte analyses performed.
1/24/2025	2018: LYM Pre-Infusion	Add	Richter’s transformation blue note box added above Q166: Richter’s Transformation: If completing the form for a recipient whose disease has undergone Richter’s transformation prior to infusion, only report therapy administered since the transformation to lymphoma on the Lymphoma Pre-Infusion (2018) Form. Any therapy given prior to transformation will be reported on the CLL Pre-Infusion (2013).
1/24/2025	4101: Post-Cellular Therapy Follow-Up	Add	New blue note box above question 21: There are currently no commercially available persistence tests for the commercially available BCMA CAR-T products (e.g. Abecma, Carvykti. You may select No for the question Were tests performed to detect persistence of the cellular product since the date of last report?.
1/24/2025	4101: Post-Cellular Therapy Follow-Up	Modify	Modified blue note box above question 21: There is a are currently no commercially available persistence tests for the commercially available CD19+ CAR-T products (e.g. Kymriah, Yescarta, Tecartus, Breyanzi , Abecma, Carvykti). You may still select No for the question Were tests performed to detect persistence of the cellular product since the date of last report? but please confirm if your site is using the new persistence test.
1/24/2025	2028: Aplastic Anemia Pre-Infusion	Add	Instructions updated to clarify leukodepleted and leukoreduced can be used interchangeably: Red blood cells may be leukodepleted (may also be documented as leukoreduced) to prevent post-transfusion complications by reducing the number of WBCs transfused. This information is typically found within the “blood blank” or “transfusion history” information. Report Yes if any of the red blood cells administered between diagnosis and the start of the preparative regimen / infusion were leukodepleted or leukoreduced. If none of the red blood cells administered between diagnosis and the start of the preparative regimen were leukodepleted or leukoreduced, report No. If it is not known if the red blood cells were leukodepleted or leukoreduced, seek clarification from the blood bank. If it cannot be determined if leukodepleted or leukoreduced red blood cells were administered prior to the start of the preparative regimen, report Unknown.
1/24/2025	2100:Post-Infusion Follow-Up Form	Add	Instructions updated how to report the work status in Q408: Select the work status that best describes the recipient’s current or most recent employment during this reporting period. If the recipient is Retired, specify their retirement status. If the recipient’s status is anything other than Full time, indicate if the recipient claimed and received medical disability due to any illness.
1/24/2025	2100:Post-Infusion Follow-Up Form	Remove	Update diabetes / hyperglycemia requiring chronic treatment description to match Table 8 in Q341 – 349: Endocrine Impairments Diabetes / hyperglycemia requiring chronic treatment: high blood glucose levels. Diabetes / hyperglycemia should only be reported if insulin and / or oral medication is required for treatment. Diabetes / hyperglycemia controlled through diet and exercise should not be reported. Only select this option if the recipient developed diabetes / hyperglycemia requiring treatment post-infusion. Do not report this disorder if the recipient had a diagnosis and was on treatment prior to infusion.
1/24/2025	2005: Confirmation of HLA Typing	Modify	Updated when the 2005 form comes due: Non-NMDP unrelated donor Non-NMDP unrelated cord blood unit Related cord blood unit HLA matched related donor HLA mismatched related donor Recipient of any of the donor types listed above Match siblings/syngeneic recipients and donors participating in the Related HCT Specimen Repository Recipient of HLA identical
1/24/2025	AML Response Criteria	Add	Example 1 and 2 updated to further clarify 0% blasts in the blood is required to report CR for recipients with MDS / MPN who transformed to AML with residual MDS / MPN: 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” if all AML criteria are met in addition to having 0 % blasts in the peripheral blood. 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” if all AML criteria are met in addition to having 0 % blasts in the peripheral blood.
1/24/2025	2402: Disease Classification	Add	ET or PCV to MDS Transformation blue box added above Q198: ET or PCV to MDS Transformation: In the rare event MDS transformed from ET or PCV, report Yes there was a predisposing condition, the condition as Other condition and specify as ET or PCV. Do not report there was a disease transformation below.
1/24/2025	2402: Disease Classification	Add	ET and PCV added as possible other predisposing conditions to report in Q199: A list of entities that would fall into the Other condition category include: ETV6-related familial thrombocytopenia, ANKRD26-related familial thrombocytopenia, SRP72-related familial aplastic anemia / MDS, MBD4-related familial leukemia, Bloom Syndrome, Noonan Syndrome, Neurofibromatosis, Downs Syndrome, ATG2B/GSKIP duplication (chromosome 14q32.2), MECOM-associated syndrome , Essential thrombocythemia (ET), Polycythemia vera (PCV).
1/124/2025	2402: Disease Classification	Modify	CALR Testing blue box updated above Q292: If CALR testing was performed and positive but the lab report does not specify the type, select Not done for CALR 1 and CALR 2, and Positive Not done for Not defined.
1/24/2025	2113: CLL Post-Infusion	Add	Clarification where MRD treatment is reported: Systemic therapy, radiation, withdrawal of immunosuppression, and/or other treatments may be administered for persistent, relapsed, or progressive disease. Additionally, therapy for measurable residual disease (MRD) may also be administered. Indicate if the recipient received treatment post-infusion for measurable residual disease (MRD), persistent, relapsed, or progressive disease in the current reporting period.
1/24/2025	2113: CLL Post-Infusion	Add	Clarified where MRD treatment is reported: Report the date when treatment for measurable residual disease (MRD), persistent, relapsed, or progressive disease was started in the current reporting period. If multiple treatments were started in the reporting period, report the date of the first treatment.
1/24/2025	2113: CLL Post-Infusion	Add	Instructions clarified to report not report MRD treatment with maintenance / consolidation: Indicate if the recipient received treatment post-infusion for reasons other than treatment for measurable residual disease (MRD), relapse, progressive, or persistent disease during the current reporting period. Recipients generally receive a HCT / cellular therapy under a specific protocol which defines radiation and / or systemic therapy to be given post-infusion, along with prophylactic medication as well as any systemic therapy, radiation, and / or other treatments to be administered post-infusion as planned (or maintenance) therapy. Planned (maintenance or consolidation) therapy is given to assist in prolonging remission. Planned therapy may be described in a research protocol or standard of care protocol and these should be referred to when completing this section. If post-infusion therapy is given as prophylaxis or maintenance for recipients in CR consider this ‘planned therapy,’ even if this was not documented prior to infusion. Do not include any treatment administered as a result of relapse, progression, or persistent disease. Indicate if therapy was given for reasons other than measurable residual disease (MRD), relapse, progressive, or persistent disease in the current reporting period.
1/24/2025	2113: CLL Post-Infusion	Add	Instructions added on how to report the best response when not in CR pre-infusion and persistent disease detected post-infusion: Use the following guidelines to determine how to report the best response when the recipient is not in CR pre-infusion and persistent disease was detected post-infusion: If the first assessments complete post-infusion are consistent with persistent disease and treatment for persistent disease was not started, report the best response as Stable disease and the assessment date as the first assessments showing stable disease. If the first assessments completed post-infusion are consistent with persistent disease and treatment for persistent disease was started, report the best response as Stable disease and the assessment date as the last assessments prior to initiating persistent disease treatment.
1/24/2025	Appendix C: Cytogenetics	Add	Chimerism Methods of Assessment section and Table 1. Chimerism Methods added to Chimerism and Cytogenetics section
1/24/2025	Appendix L: Karnofsky / Lansky Performance Status	Modify	Version 2 of Appendix L: Karnofsky / Lansky Performance Status released with the Winter 2025 Quarterly release

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