CIBMTR.org

2022 Manual Updates

January 2022
February 2022
March 2022
April 2022
May 2022
August 2022
September 2022
October 2022
November 2022
December 2022

Updates made during the current calendar year are included below. For updates prior to 2022, 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.

December 2022

12/12/2022 4100 Post-CTED Modify Clarified when to report other grade 4 organ toxicities/symptoms: If Other is selected, then the grade 4 toxicities / symptoms that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
12/12/2022 4100 Post-CTED Modify Clarified when to report other grade 3 organ toxicities/symptoms: If Other is selected, then the grade 3 toxicities / symptoms that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.

November 2022

11/15/2022 Q89-202: Toxicities Modify Clarified how to report a fever documented from a home test: Fevers (≥100.4F or ≥38C): A disorder characterized by elevation of the body’s temperature above the upper limit of normal. Do not report fever if less than 100.4F or 38C in this field. Fever less than 100.4F or 38C does not qualify as a symptom of CRS. Report the date of fever onset in question 87. If there were multiple fevers in the reporting period, report the first occurrence. If the recipient self-reported a fever from a home test, and the date is documented in the medical records, report the date of the home test.
11/14/2022 2199: Donor Lymphocyte Infusion Modify Added sentence about time point of best response: Report best response to DLI when the assessment was done per routine clinical evaluation, within 30-60 days post-infusion, and prior to any subsequent DLI.

October 2022

10/27/2022 Q1-31: Product Identification Modify Added CarvyktiTM to the blue note box above below14: If the cellular therapy product infused is the commercially available product Kymriah® ,or BreyanziTM, Abecma®, or CarvyktiTM this question will be disabled.
10/20/2022 MPN Response Criteria Add The Determining Post-Infusion Baseline Assessments blue box added: Determining Post-Infusion Baseline Assessments When determining the post-infusion disease status, the most recent lab values prior to the start of the preparative regimen should be used as the baseline assessments. However, if relapse or progression occurs after infusion, the labs from relapse / progression should be used.
10/20/2022 MPN Response Criteria Add The Determining Pre-Infusion Baseline Assessments blue box added: Determining Pre-Infusion Baseline Assessments When determining the pre-infusion disease status, use the lab values from diagnosis of the primary disease for infusion as the baseline assessments. However, if relapse or progression occurs prior to infusion, the labs from relapse / progression should be used.
10/20/2022 MDS Response Criteria Add The Determining Post-Infusion Baseline Assessments blue box added: Determining Post-Infusion Baseline Assessments When determining the post-infusion disease status, the most recent lab values prior to the start of the preparative regimen should be used as the baseline assessments. However, if relapse or progression occurs after infusion, the labs from relapse / progression should be used.
10/20/2022 MDS Response Criteria Add The Determining Pre-Infusion Baseline Assessments blue box added: Determining Pre-Infusion Baseline Assessments When determining the pre-infusion disease status, use the lab values from diagnosis of the primary disease for infusion as the baseline assessments. However, if relapse or progression occurs prior to infusion, the labs from relapse / progression should be used.
10/20/2022 2400: Pre-TED Add Instructions for Q17 – 18 updated to include PedAL option: If the study sponsor is reported as USIDNET, COG, or PedAL continue with Subject ID.
10/20/2022 2400: Pre-TED Add Instructions for Q16 updated to include PedAL option: Indicate if the recipient is a registered participant with BMT-CTN, RCI-BMT, USIDNET, COG, PedAL and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes data.
10/18/2022 2400: Pre-TED Add Clarification added on how to answer Q135 – 139 when peri-transplant drugs were not given: If the recipient did not receive any of the drugs listed above, leave these questions blank and override the error as ‘verified correct.’
10/17/2022 4100 Post-CTED Modify Updated the continue with question number: If the reason for the new course of cellular therapy was Failure to respond or in response to disease assessment or for a New indication, continue with question 10 6 to report the event date.
10/17/2022 4000: Cellular Therapy Essential Data Pre-Infusion Modify Removed the following text: Indicate whether the total serum ferritin result was Known or Unknown prior to the start of lymphodepleting therapy. If Known, report the result and the unit of measure in question 102, and report the date (MM-DD-YYYY) of the test in question 103.
10/17/2022 2016: PCD Pre-Infusion Add Q181 updated for clarification: Cellular therapy treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g., cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR-T cells). Report Yes if the recipient received cellular therapy as part of the line of therapy being reported. For subsequent infusions, this includes any previous cell therapy infusions to treat disease already reported to the CIBMTR. If not, report No.
10/17/2022 2018: LYM Pre-Infusion Add The instructions for question 216 were updated: Cellular therapy treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g., cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR T-cells). Report “Yes” if the recipient received cellular therapy as part of the line of therapy being reported. For subsequent infusions, this includes any previous cell therapy infusions to treat disease already reported to the CIBMTR. If not, report “No.”
10/17/2022 2011: ALL Pre-Infusion Add Additional information added for clarification: Cellular therapy treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g., cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR T-cells). Report “Yes” if the recipient received cellular therapy as part of the line of therapy being reported. For subsequent infusions, this includes any previous cell therapy infusion to treat disease already reported to the CIBMTR. If not, report “No.”
10/17/2022 2402: Disease Classification Modify Instructions updated for Q391 updated for clarification: Histologic transformation may occur after CLL diagnosis. Indicate if CLL transformed into diffuse large B-cell lymphoma (known as Richter’s transformation or Richter’s syndrome). If CLL transformed, select Yes, and continue with the Hodgkin / Non-Hodgkin Lymphoma section. If CLL did not transform, select No and report the disease status. Always report this question as No. This question will be updated in future releases. If CLL transformed, the primary disease should be reported as Hodgkin lymphoma or Non-Hodgkin’s lymphoma – do not report the primary disease as Other leukemia.
10/17/2022 2402: Disease Classification Add Red instruction box added above Q391: CLL with Richter’s Transformation If the recipient is receiving an infusion for CLL and there was a Richter’s transformation to lymphoma, the primary disease for infusion should be reported as Hodgkin lymphoma (150) or Non-Hodgkin’s lymphoma (100) and not Other Leukemia (30).
10/17/2022 LYM Response Criteria Add Blue instruction box added to clarify an MRI may be used in place of a CT for the radiographic response criteria for recipients with CNS lymphoma.
10/10/2022 4100 Post-CTED Modify Clarified in questions 92-94 what not to report for other CRS therapy (in red): Examples of what not to report as other therapy include, but are not limited to, acetaminophen (Tylenol®) albumin, antibiotics, IV fluids, or any brand name or specific corticosteroids administered.
10/10/2022 4100 Post-CTED Modify Clarified in questions 95-105 what not to report for other hypotension therapy (in red): Examples of what not to report as other therapy include, but are not limited to, acetaminophen (Tylenol®) albumin, antibiotics, IV fluids, or any brand name or specific corticosteroids administered.

September 2022

9/29/2021 4006: Cellular Therapy Infusion Modify Added CarvyktiTM to the blue note box above question 14: Product specific reporting guides for reporting cells administered can be requested for Kymriah®, BreyanziTM, Abecma®, and CarvyktiTM by contacting CIBMTR Center Support.
9/29/2022 4000: Cellular Therapy Essential Data Pre-Infusion Add Added blue note box above question 122: Prior to answering Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI) question, review the list of co-existing disease(s) and/or organ impairments listed below.
9/29/2022 4000: Cellular Therapy Essential Data Pre-Infusion Modify Updated text in red: Current Diagnosis at the Time of Pre- Infusion Evaluation
9/29/2022 4000: Cellular Therapy Essential Data Pre-Infusion Modify Moved ‘Rheumatologic’ and ‘Prior malignancy, requiring treatment’ to the Documented medical history list. Added ‘heart value disease’ under Current Diagnosis at the Time of Pre-Infusion Evaluation
9/29/2022 4000: Cellular Therapy Essential Data Pre-Infusion Modify Removed text from the blue note box: Hepatic and Renal Comorbidities Report all comorbidities including those that are considered complications of the primary disease for infusion. See examples below.
9/23/2022 Appendix J: Reporting Comorbidities Add Update infection criteria to be consistent with Pre-TED (2400) released on 9/23/2022: The presence of one or more of the following requiring continuation of therapeutic antimicrobial / antifungal / antiviral treatment after Day 0: Therapy must have started prior to the start of the preparative regimen / infusion with the recommendation documented to continue therapy after the infusion.
9/21/2022 2018: LYM Pre-Infusion Modify Instructions above Q234 were updated: All values reported in questions 234-288 must reflect the most recent testing prior to the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy was given). Do not report testing performed during a line of therapy reported in questions 167-223. If testing was not performed near the start of the preparative regimen / lymphodepleting therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable), the center should -report -“Unknown” No for that value.
9/21/2022 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Instructions for Q173 updated: Indicate if the myelofibrosis grade by WHO classification was bone marrow biopsy results were considered a disease relapse. Criteria for myelofibrosis relapse are established by clinical judgment. If the recipient has a myelofibrosis grade by WHO classification that the physician considers to be bone marrow biopsy was consistent with relapse, select “yes.” Continue with question 174.
9/21/2022 MDS Post-HCT Modify Instructions for Q143 updated as original instructions were incorrect: Indicate if the myelofibrosis grade by WHO classification was bone marrow biopsy results were considered a disease relapse. Criteria for myelofibrosis relapse are established by clinical judgment. If the recipient has a myelofibrosis grade by WHO classification that the physician considers to be bone marrow biopsy is consistent with relapse, select “yes.” Continue with question 144.
9/20/2022 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Update instructions to be consistent with question text: If a disease was detected via bone marrow examination (color-red) was performed at the time of best response, select “yes” for question 73 and report the date the sample was collected in question 74. If a bone marrow examination was not performed disease was not detected or it is unknown if %(color-red)completed disease was detected via bone marrow examination at the time of best response, select “no” or “unknown” and continue with question 80.
9/16/2022 MDS Post-HCT Modify Instructions for Q59 updated to be consistent with question text: If disease detected a bone marrow examination was performed at the time of best response, select “yes” for question 59 and report the date the sample was collected in question 60. If a bone marrow examination disease was not performed or it is unknown if disease was detected via performed at the time of best response, select “no” or “unknown” and continue with question 65.
9/11/2022 2018: LYM Pre-Infusion Add Q217 and 219 were updated to clarify a scan performed during the line of therapy can be reported as the best response: The instructions for question 219 were updated: _Indicate the best response to the line of therapy by PET using the international working group metabolic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. The best response may occur during or after the line of therapy. Report “Not assessed” if a PET scan was not performed during after the line of therapy being reported and prior to the initiation of any new therapy.
9/9/2022 Appendix J: Reporting Comorbidities Add Update psychiatric criteria to be consistent with Pre-TED (2400) form: Any psychiatric illness requiring continuous psychiatric treatment within four weeks prior to the pre-transplant work-up period. Examples include depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), schizophrenia, or bipolar disorder.

August 2022

8/12/2022 2011: ALL Pre-Infusion Add Additional information added for clarification: Indicate whether the percent blasts in the peripheral blood is “Known” or “Unknown” at the time of diagnosis. This may be determined by an automated differential, a manual count, or flow cytometry. Testing by any of these methods may be reported in questions 4-6. If “Known,” report the laboratory value, unit of measure, and date sample collected. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms. If the percent blasts in blood at diagnosis is not known, report “Unknown” and go to question 7. If a differential was performed and there were no blasts present in the peripheral blood, the lab report may not display a column for blasts. In this case, it can be assumed no blasts are present and ‘0’ should be reported.
8/12/2022 2010: AML Pre-Infusion Add Additional instructions added for clarification: Indicate whether the percent blasts in the peripheral blood is “Known” or “Unknown” at the time of diagnosis. This may be determined by an automated differential, a manual count, or flow cytometry. Testing by any of these methods may be reported in questions 17-19. If “Known,” report the laboratory value, unit of measure, and date sample collected. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms. If the percent blasts in blood at diagnosis is not known, report “Unknown” and go to question 20. If a differential was performed and there were no blasts present in the peripheral blood, the lab report may not display a column for blasts. In this case, it can be assumed no blasts are present and ‘0’ should be reported.
8/12/2022 2011: ALL Pre-Infusion Add Additional information added for clarification: Indicate whether the percent blasts in the peripheral blood is “Known” or “Unknown” at the last evaluation prior to the start of the preparative regimen / infusion. This may be determined by an automated differential, a manual count, or flow cytometry. Testing by any of these methods may be reported in questions 67-69. If “Known,” report the laboratory value, unit of measure, and date sample collected. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms. If the percent blasts in blood at the last evaluation prior to the start of the preparative regimen / infusion is not known, report “Unknown” and go to question 70. If a differential was performed and there were no blasts present in the peripheral blood, the lab report may not display a column for blasts. In this case, it can be assumed no blasts are present and ‘0’ should be reported.

May 2022

5/20/2022 2116: PCD Post-Infusion Add Clarification added that Q160 will not come due when NA is reported: Indicate if the date the radiation therapy stopped is Known, Unknown, or Not applicable. If Known, enter the date the line of radiation therapy ended. Report Not applicable if the recipient is still receiving therapy. When Not applicable is selected, the radiation dose will not be reported in the next question. However, once radiation stops (i.e., the radiation stop date is Known), the dose will be reported.
5/20/2022 2116: PCD Post-Infusion Add Instructions added on how to report the total dose when radiation continued from the prior reporting period: If radiation started in a previous reporting period (i.e., Not applicable was reported as the therapy end date for the prior reporting period) and continued into the current reporting period, report the total dose administered since radiation started (including the doses given in the previous reporting period).
Example B: A recipient started radiation at end of the Day 100 reporting period. 200 cGy for 3 doses were given (total dose in the Day 100 reporting period is 600 cGy). Radiation continued into the 6-month reporting period and an additional 200 cGy for 4 doses were given (total dose given in the 6-month reporting period is 800 cGy). The total dose of radiation should be reported as 1400 cGy (600 cGy + 800 cGy).
5/19/2022 2100:Post-Infusion Follow-Up Form Modify Updated the ‘go to’ instructions for Q311: Report Yes if the plan was to complete all conditioning, infusions, and recovery in the outpatient setting. If the plan was to admit the patient for any part of the transplant, report No and continue with question 315 312.
5/19/2022 2450: Post-TED Add Reporting ‘No’ for Clinical / Hematologic Assessments blue instruction box added above Q104
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report yes and no for Q104: If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 107 Yes If assessments were performed prior to relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No If assessments were not performed prior to relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 87) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 107. Yes if disease assessments were performed within the time windows in the Disease Assessment Time Windows table above. If testing was not performed within the applicable time window, report No
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report the assessment date for Q105: If the best response is Not in complete remission – no disease detected but incomplete evaluation to establish CR, report the date of the most clinical / hematologic recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date. last assessment performed in the reporting period and prior to relapse, progression, or treatment for persistent disease, if applicable. If the best response is Not in complete remission – disease detected, report the most recent assessment performed in the reporting period that detects disease and prior to progression or treatment for persistent disease, if applicable. If disease was not detected by this method report the date of the most recent assessment performed and prior to relapse, progression or treatment for persistent disease, if applicable.
5/19/2022 2450: Post-TED Modify Instructions clarified on when to report no and yes for Q101: Report No if radiologic assessments were not performed during the reporting period positive for disease in the past but not performed during the current reporting period.
If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 104 Yes if assessments were performed, prior to any relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No if assessments were not performed, prior to any relapse, progression, or treatment for persistent disease (excluding treatment for minimal residual disease).
If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 87) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 104. Yes if disease assessments were performed within the time windows in the Disease Assessments Time Windows table above. If testing was not performed within the applicable time window, report No.
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report the assessment date for Q102: If the best response is Complete remission, report the date of the assessment performed nearest the date of best response within the time window and prior to relapse or progression, if applicable. If the best response is Not in complete remission – no disease detected but incomplete evaluation to establish CR, report the date of the most recent radiological testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most recent radiological assessment performed within approximately 30 days of the follow-up date last assessment performed in the reporting period and prior to relapse, progression, or treatment for persistent disease, if applicable. If the best response is Not in complete remission – disease detected, report the most recent radiologic testing performed in the reporting period that detects disease *and prior to progression or treatment for persistent disease, if applicable. If disease was not detected by this method, report the date of the most recent radiological testing performed and prior to relapse, progression, or treatment for persistent disease, if applicable.. Report the date of radiological assessment. For recipients with Complete remission reported in question 85, this This date may match the date CR was achieved reported in question 87 for recipients with lymphomas, solid tumors, or other diseases with imaging criteria for reporting CR.
5/19/2022 2450: Post-TED Modify Instructions clarified on when to report no and yes for Q98: Report No if karyotyping studies were not performed during the reporting period positive for disease in the past but not performed during the current reporting period.
If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 101 Yes if assessments were performed, prior to any relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No if assessments were not performed, prior to any relapse, progression, or treatment for persistent disease (excluding treatment for minimal residual disease).
If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 87) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 101. Yes if disease assessments were performed within the time windows in the Disease Assessments Time Windows table above. If testing was not performed within the applicable time window, report No.
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report the assessment date for Q99: If the best response is Complete remission, report the date of testing performed nearest the date of best response within the time window and prior to relapse or progression, if applicable. If the best response is Not in complete remission, report the date of the most recent karyotype testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most recent karyotype assessment performed within approximately 30 days of the follow-up date. any relapse, progression or treatment for persistent disease, if applicable.
5/19/2022 2450: Post-TED Add Instructions clarified on how to report yes for Q100: Report whether the recipient’s primary disease was detected by karyotyping on the date reported in question 100. Do not include clinically insignificant polymorphism, or chromosomal abnormalities of no known significance, as disease detected; this includes anomalies such as age-dependent loss of the chromosome Y This question may be reported as Yes even when Not in complete remission – no disease detected but incomplete evaluation to establish CR is reported as the best response.
5/19/2022 2450: Post-TED Add Instructions clarified on how to report yes for Q97: Report whether the recipient’s primary disease was detected by FISH testing on the date reported in question 96 This question may be reported as Yes even when Not in complete remission – no disease detected but incomplete evaluation to establish CR is reported as the best response.
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report the assessment date for Q96: If the best response is Complete remission, report the date of testing performed nearest the date of best response within the time window and prior to relapse or progression, if applicable. If the best response is Not in complete remission, report the date of the most recent FISH testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most recent flow cytometry assessment performed within approximately 30 days of the follow-up date. any relapse, progression or treatment for persistent disease, if applicable.
5/19/2022 2450: Post-TED Modify Instructions clarified on when to report no and yes for Q95: Report No if FISH studies were not performed during the reporting period positive for disease in the past but not performed during the current reporting period.
If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 98 Yes if assessments were performed, prior to any relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No if assessments were not performed, prior to any relapse, progression, or treatment for persistent disease (excluding treatment for minimal residual disease).
If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 87) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 98. Yes if disease assessments were performed within the time windows in the Disease Assessments Time Windows table above. If testing was not performed within the applicable time window, report No.
5/19/2022 2450: Post-TED Modify Instructions clarified on when to report no and yes for Q94: Report No if cytogenetic studies were not performed during the reporting period positive for disease in the past but not performed during the current reporting period.
If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 101 Yes if assessments were performed, prior to any relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No if assessments were not performed, prior to any relapse, progression, or treatment for persistent disease (excluding treatment for minimal residual disease).
If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 87) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 101. Yes if disease assessments were performed within the time windows in the Disease Assessments Time Windows table above. If testing was not performed within the applicable time window, report No.
5/19/2022 2450: Post-TED Add Instructions clarified on how to report yes for Q93: Report whether the recipient’s primary disease was detected by flow cytometry on the date reported in question 93. Report Yes if an abnormal cell population associated with the recipient’s primary transplant disease was detected regardless of the sensitivity of the flow cytometry panel performed; this means an abnormal cell population detected by MRD flow cytometry would be reported in the same way as an abnormal cell population detected by a standard flow cytometry assay. This question may be reported as Yes even when Not in complete remission – no disease detected but incomplete evaluation to establish CR is reported as the best response.
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report the assessment date for Q92: If the best response is Complete remission, report the date of testing performed nearest the date of best response within the time window and prior to relapse or progression, if applicable. If the best response is Not in complete remission, report the date of the most recent flow cytometry testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most recent flow cytometry assessment performed within approximately 30 days of the follow-up date. any relapse, progression or treatment for persistent disease, if applicable.
5/19/2022 2450: Post-TED Modify Instructions clarified on when to report no and yes for Q91: Report No if flow cytometry was not performed during the reporting period studies were positive for disease in the past but not performed during the current reporting period.
If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 94 Yes if assessments were performed, prior to any relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No if assessments were not performed, prior to any relapse, progression, or treatment for persistent disease (excluding treatment for minimal residual disease).
If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 88) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 94. Yes if disease assessments were performed within the time windows in the Disease Assessments Time Windows table above. If testing was not performed within the applicable time window, report No.
5/19/2022 2450: Post-TED Add Instructions clarified on how to report yes for Q90: Report whether the recipient’s primary disease was detected by molecular testing on the date reported in question 89. This question may be reported as Yes even when Not in complete remission – no disease detected but incomplete evaluation to establish CR is reported as the best response. In order to be considered positive for disease, the assay must detect a number of copies of the molecular marker exceeding the threshold for sensitivity of the assay, for a quantitative study. However, do note that presence of only a single marker among numerous tested is sufficient to indicate disease detected.
5/19/2022 2450: Post-TED Modify Instructions clarified on how to report the assessment date for Q89: If the best response is Complete remission, report the date of testing performed nearest the date of best response within the time window and prior to relapse or progression, if applicable. If the best response is Not in complete remission, report the date of the most recent molecular testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most recent molecular assessment performed within approximately 30 days of the follow-up date. any relapse, progression or treatment for persistent disease, if applicable.
5/19/2022 2450: Post-TED Modify Instructions clarified on when to report no and yes for Q88: Report No if molecular studies were not performed during the reporting period positive for disease in the past but not performed during the current reporting period.
If the recipient’s best response is Not in Complete Remission, report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report No and go to question 91. Yes if assessments were performed, prior to any relapse, progression or treatment for persistent disease, (excluding treatment for minimal residual disease). Report No if assessments were not performed, prior to any relapse, progression, or treatment for persistent disease (excluding treatment for minimal residual disease).
If the recipient’ best response is Complete Remission, report testing performed closest to the date of best response (question 87) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report No and go to question 91. Yes if disease assessments were performed within the time windows in the Disease Assessments Time Windows table above. If testing was not performed within the applicable time window, report No.
5/19/2022 2450: Post-TED Modify Clarification added on when to select Disease detected for question 85: If disease persists by any radiological or clinical / hematological assessment indicate Disease detected. Persistence of abnormalities by molecular, cytogenetic, or flow cytometry assessments does not constitute “disease detected” and should not be reported as ‘disease detected’ for this question. Indicate Disease detected if disease persists by any method of radiological or clinical assessment; persistence of abnormalities by molecular, cytogenetic, or flow cytometry assessments does not constitute “disease detected.”
5/18/2022 2100:Post-Infusion Follow-Up Form Add Combined Follow-Up blue instruction box added to questions 6, 13, 17, 26, 70, 208, 224, 241, 310, and 325 for clarification on when these questions will come due.
5/18/2022 2450: Post-TED Add The Combined Follow Up blue instruction box were added to questions 14, 17, 50, 57, 84, 107, 112, 115, and 123 for clarification on when these questions will come due.
5/18/2022 2402: Disease Classification Add DLBCL and Relapse with Follicular Lymphoma blue instruction box added for clarification to Q394: In some scenarios, a recipient may be diagnosed with DLBCL and then later, relapses with Follicular lymphoma prior to infusion. In these cases, it is important to determine the primary disease for infusion with the physician. If primary disease for infusion is Follicular lymphoma, report the pre-infusion disease status since the diagnosis of the Follicular lymphoma (not since the diagnosis of DLBCL). If the primary disease for infusion is DLBCL, report the pre-infusion disease status since the original diagnosis of DLBCL.
5/18/2022 2402: Disease Classification Add DLBCL and Relapse with Follicular Lymphoma blue instruction box added for clarification to Q384: In some scenarios, a recipient may be diagnosed with DLBCL and then later, relapses with Follicular lymphoma prior to infusion. In these cases, it is important to determine the primary disease for infusion with the physician. If primary disease for infusion is Follicular lymphoma, report ‘no’ there was not a transformation. However, on the Pre-TED (2400) form, report there was a previous malignancy of lymphoma. If the primary disease for infusion is DLBCL, report ‘yes’ there was a transformation and the date of the original lymphoma diagnosis as the date when the recipient was diagnosed with DLBCL (i.e., question 1 and question 387 will be the same) as it is presumed Follicular lymphoma was present all along.
5/18/2022 2402: Disease Classification Add DLBCL and Relapse with Follicular Lymphoma blue instruction box added to Q379 for clarification: In some scenarios, a recipient may be diagnosed with DLBCL and then later, relapses with Follicular lymphoma prior to infusion. In these cases, it is important to determine the primary disease for infusion with the physician. If the primary disease for infusion is Follicular lymphoma, report the diagnosis date as the date when the recipient was diagnosed with Follicular lymphoma (i.e., the relapse date) and report the lymphoma histology for infusion as ‘Follicular lymphoma.’ If the primary disease for infusion is DLBCL, report the diagnosis date as the date the recipient was diagnosed with DLBCL and report the lymphoma histology for infusion as ‘DLBCL.’
5/18/2022 LYM Response Criteria Add Blue instruction box added for instructions on how to report the scenario where a recipient relapses with a less severe type of lymphoma post-infusion.
5/18/2022 LYM Response Criteria Add Blue instruction box added for clarification that Deauville scores not required to report a disease status for the metabolic criteria.
5/18/22 Amyloidosis Response Criteria Add The Consecutive Assessment Requirements blue instruction box added: The Hematologic Response requires two consecutive assessments made by the same method at any time before the institution of any new therapy. Organ responses (i.e., Hepatic, Peripheral Neuropathy, Cardiac) do not require confirmatory assessments.
5/18/22 Amyloidosis Response Criteria Modify The Partial Response criteria for Hematologic Response was updated to be consistent with the Working Group Response criteria:
  • ≥ 50% decrease in clonal serum free light chain levels difference between the involved and uninvolved serum free light chain (if >10 mg / dL or >100 mg / L at baseline)
5/18/22 Amyloidosis Response Criteria Modify Cardiac response criteria update to be consistent with Working Group Response criteria. Cardiac response: ≥ 2 mm decrease in mean intraventricular septal wall thickness by echocardiogram, ≥ 20% increase in left ventricular ejection fraction, ≥ 2 grade decrease in New York Heart Association functional class without increase in diuretic use and no increase in wall thickness, Reduction (≥ 30% and ≥ 300ng/L) of NT-proBNP in patients whom the eGFR is ≥ 45 ml/minute/1.73m2 > 30 % and > 300 ng /l decrease in recipients with baseline N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 650 ng/L or ≥ 2 class decrease in recipients with baseline New York Heart Association class of 3 or 4 Progressive disease: ≥ 2 mm increase from baseline in the intraventricular wall thickness by echocardiogram, ≥ 10% decrease in the left ventricular ejection fraction, ≥ 1 grade increase in New York Heart Association functional class > 30 % and > 300 ng/l increase in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) or ≥ 33 increase in cardiac troponin (cTn) or ≥ 10% decrease in ejection fraction%
5/18/2022 POEMS Response Criteria Remove POEMS Partial Response Criteria update to be more concise as the first bullet point was the same criteria for VGPR: One or more of the following must be present:
  • Serum M-protein detectable by immunofixation
  • A ≥ 50% reduction in the serum M-protein as long as the serum M-protein was ≥ 1.0 g/dL at baseline
5/13/2022 2402: Disease Classification Modify Clarified the instructions on how to report the units of measurement for LDH in question 426: Indicate the upper limit of normal for LDH value and the unit of measure as listed on the laboratory report used at your institution.
5/10/2022 4006: Cellular Therapy Infusion Modify Removed Breyanzi from the blue note box below question 14: If the cellular therapy product infused is the commercially available product Kymriah® , BreyanziTM, or Abemca®, this question will be disabled.
5/6/2022 2100:Post-Infusion Follow-Up Form Modify Clarification added on when to report organ impairments in question 280: Indicate if any of the organ impairments or disorders listed were diagnosed during the reporting period. If the recipient developed an impairment during the reporting period, select the impairment / disorder, enter the date of diagnosis, and answer any additional questions pertaining to the impairment / disorder. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported. *Do not report organ impairments or disorders diagnosed prior to the start of the preparative regimen infusion /or in a prior reporting period.
5/6/2022 2100:Post-Infusion Follow-Up Form Modify Updated instructions on when to report the antiviral start date as 7 days prior to prep in Q213 – 215: Report the first antiviral drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antiviral drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. If the start date is prior to the start of the preparative regimen and the start date is unknown known, report the date as seven days prior the start of the preparative regimen. Only one antiviral drug may be reported.
5/6/2022 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion Modify Clarified instructions on how to report the best response to therapy assessment date for question 206: Enter the date of the most recent assessment of disease status prior to the start of the preparative regimen. The date reported should be that of the most disease-specific assessment within the pre-transplant work-up period (approximately 30 days). Clinical and hematologic assessments include pathological evaluation (e.g., bone marrow biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician evaluation and physical examination. Enter the date the sample was collected for pathological and laboratory evaluations; enter the date the imaging took place for radiographic assessments. Enter the date the best response to the line of therapy was established. Report the date of the pathological evaluation (e.g., bone marrow biopsy), or the date of blood/serum assessment (e.g., CBC, peripheral blood smear) used to establish the best response to the line of therapy. Enter the date the sample was collected for pathological and/or laboratory evaluations. If the recipient was treated for extramedullary disease and a radiological assessment (e.g., X-ray, CT scan, MRI scan, PET scan) was performed to assess disease response, enter the date the imaging took place for radiologic assessments. If no pathological, radiographic, or laboratory assessment was performed to establish the best response to the line of therapy, report the office visit in which the physician clinically assessed the recipient’s response)
5/6/2022 2402: Disease Classification Modify Clarified instructions on how to report spleen response in question 365: A spleen response can be documented by a physician or but should be confirmed by MRI / computed tomography showing ≥35 % spleen volume reduction.
5/6/2022 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Modify Clarified instructions on how to report spleen response in question 3: A spleen response can be documented by a physician or but should be confirmed by MRI / computed tomography showing ≥35 % spleen volume reduction.
5/6/2022 2157: Myeloproliferative Neoplasm (MPN) Post-HCT Add Clarification added above question 105 (blue note box and instructional text) to report the first assessment showing evidence of disease: Questions 105 – 202 are intended to capture the earliest instance of disease detection by each method of assessment performed during the reporting period. If multiple tests by a particular method have demonstrated evidence of disease during the reporting period, report the date / result of the earliest positive assessment(s) performed during the reporting period.
For each method of assessment, report “Yes” if that method detected the recipient’s MPN (or markers of MPN) during the reporting period. If testing by a particular method (e.g., molecular makers, cytogenetic, flow cytometry, etc.) was done, but did not shown evidence of disease during the reporting period, report “No” for that method. If testing for splenomegaly, hepatomegaly, driver mutations, molecular or cytogenetic markers / abnormalities, or disease detected via bone marrow was not done during the reporting period or it is not known whether testing was performed, report “Unknown” for those methods. If testing by flow cytometry or for disease detected extramedullary or by other assessment was not done during the reporting period or it is not known whether testing was performed, report “No” for those methods.
5/6/2022 2450: Post-TED Modify Clarified instructions on how to report the best response for tandem transplants: Tandem Transplants: For recipients receiving a tandem transplant, the best response to the prior transplant (i.e., HCT #1 of the tandem) depends on the pre-transplant disease status.
  • If the recipient was in complete remission at the time of HCT #1 or achieved complete remission prior to HCT #2 of their tandem transplant, report the best response to transplant as Continued complete remission (CCR)
  • If the recipient was not in complete remission or did not achieve complete remission in response to HCT #1 prior to HCT #2 of their tandem transplant, either “Not in complete remission (NCR)” or “Not evaluated” would be appropriate options, however, ensure the best response to transplant and the current diseases status are answered consistently
  • If the recipient was not in complete remission at the time of HCT #1, and no disease assessments (including labs and / or physician’s exams) occurred in the reporting period, between HCT #1 and HCT #2 of their tandem transplant, report Not evaluated. However, ensure the best response to transplant and the current disease status are reported consistently
  • If the recipient was not in complete remission at the time of HCT #1, and achieved complete remission prior to HCT #2 of their tandem transplant, report Complete remission, the date which a complete remission was achieved
  • If the recipient was not in complete remission at the time of HCT #1 and did not achieve complete remission in response to HCT #1 and prior to HCT #2 of their tandem transplant, report Not in complete remission (NCR)

April 2022

4/22/2019 2158: Thalassemia Post-Infusion Add Version 1 of the 2158: Thalassemia Post-Infusion section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 2158.
4/22/2019 2058: Thalassemia Pre-Infusion Add Version 1 of the 2058: Thalassemia Pre-Infusion section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 2058.
4/11/22 4100 Post-CTED Add Clarification added on reporting COVID-19 infections for subsequent infusions & possible reporting scenarios: Do NOT report an infection in the following scenarios:
A recipient only has a positive antibody result.
The recipient was symptomatic and treated but COVID-19 diagnostic testing was not performed and / or COVID-19 diagnostic testing was performed and negative.
DO report an infection in the following scenarios:
A recipient has a positive COVID-19 diagnostic result (PCR or antigen) or if treatment was given or if the recipient was asymptomatic.
A recipient has a positive antibody result and a positive COVID-19 diagnostic test (PCR or antigen)
4/11/22 4000 Pre-CTED Add Clarification added on what to report if vaccine brand is Unknown: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify in question 115. If the vaccine brand is unknown, leave the field blank and override the error as Unknown.
4/11/22 4000 Pre-CTED Add COVID-19 Vaccine blue box added above question 109: COVID-19 Vaccine
If the recipient received a COVID-19 vaccine at any time prior to July 2021 (before the COVID-19 vaccine questions were available on the Cellular Therapy Essential Data Pre-Infusion (4000) form), select Yes for question 109 at the first opportunity this form becomes available. When reporting the vaccine date, report the actual date the recipient received the vaccine.
4/11/22 4000 Pre-CTED Add Instruction added for documenting COVID-19 infections for subsequent infusion: Do NOT report an infection:
• A recipient has a positive antibody result. They do not have a history of positive COVID diagnostic results (PCR or antigen).
• The recipient was symptomatic and treated but COVID-19 diagnostic testing was not performed and/or COVID diagnostic testing was performed and negative.
DO report an infection:
• A recipient has a positive COVID diagnostic result (PCR or antigen). No treatment was given and/or recipient was asymptomatic.
4/11/2022 4003: Cellular Therapy Product Add Instruction added for the preferred timepoint of viability when the product was cryopreserved: If the product was cryopreserved, viability post-thaw should be reported.
4/11/2022 4100 Post-CTED Add COVID-19 Reinfection blue box added above Q204-208: Reporting COVID-19 Reinfection: There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).
4/11/2022 4100 Post-CTED Add Clarification added in regard to revaccination post-infusion: Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) within the current reporting period. If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively, and continue with question 214. Revaccination Post-Infusion: When vaccines are given post-infusion, the physician should make the determination on whether the doses are part of the primary series of vaccines, third primary dose, boosters, or revaccination. If a recipient receives a new course of COVID vaccines following infusion as revaccination, report the vaccines as a new series. The most up to date CDC COVID-19 vaccine information for immunocompromised people can be found here.
4/11/2022 4100 Post-CTED Modify Updated blue box above Q210-211 how to report multiple vaccine doses: COVID-19 Vaccine Doses
FormsNet3SM application: Complete questions 210 – 213 to report all COVID-19 vaccine doses received in the current reporting period by adding an additional instance in the FormsNet3SM application. A separate instance should be added for each dose.
Paper form submission: Copy questions 210 – 213 and complete report all COVID-19 vaccine doses received in the current reporting period. A separate instance should be completed for each dose.
4/11/2022 4100 Post-CTED Modify/Add Updated question instructions: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify. If the vaccine brand is unknown, leave the field blank and override the error as Unknown. Third dose versus Booster dose blue box added above question 210-211: Third dose versus Booster dose: To determine between a third dose and a booster dose, seek clinician clarification, as needed, using the guidelines listed below:
Third dose: An additional primary dose required for recipients who did not build enough protection from their primary vaccine series, typically for immunocompromised individuals
Booster dose: Administered to recipients who have enough protection after completing their primary vaccine series but then protection decreases over time
Primary vaccine series: Two doses of Pfizer-BioNTech or Moderna One dose of Johnson & Johnson’s Janssen.
4/11/2022 4100 Post-CTED Modify Updated question instructions: For the reported dose, specify the vaccine dose the recipient in the current reporting period and specify the date when the dose was received
4/11/2022 4100 Post-CTED” Add Additional example (#5) added to clarify hypogammaglobulinemia reporting: Example 5. For an adult recipient, IgG levels were below 600 mg/dL pre-infusion and immunoglobulin replacement therapy (IVIG) was given pre-infusion. Post-infusion, all IgG values were greater than 600 mg/dL and never dropped below 600 mg/mL. This is not reported as a toxicity since the IgG levels were never below 600 mg/dL after infusion.
4/11/2022 Add Instruction added for the preferred timepoint of viability when the product was cryopreserved: If the product was cryopreserved, viability post-thaw should be reported.
4/11/2022 2100:Post-Infusion Follow-Up Form Add Instructions added to question 246 on how to report the vaccine brand when not known for clarification: Specify the type of COVID-19 vaccine the recipient received in the reporting period. If the recipient received a type that is not listed, select Other type and specify the vaccine. If the vaccine type is unknown, leave the field blank and override the error as Unknown.
4/11/2022 2100:Post-Infusion Follow-Up Form Add Reporting COVID-19 Reinfection blue box and possible COVID-19 reporting scenarios added above Q224 for clarification: Reporting COVID-19 Reinfection: There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).; Possible COVID-19 Reporting Scenarios: Do NOT report an infection in the following scenarios:
  • A recipient only has a positive antibody result
  • The recipient was symptomatic and treated but COVID-19 diagnostic testing was not performed and / or COVID-19 diagnostic testing was performed and negative DO report an infection in the following scenarios:
  • A recipient has a positive COVID-19 diagnostic result (PCR or antigen), regardless of if treatment was given or if the recipient was asymptomatic
  • A recipient has a positive antibody result and a positive COVID-19 diagnostic test (PCR or antigen)
4/11/2022 4100: Post-CTED Add Additional example (#5) added to clarify hypogammaglobulinemia reporting
4/8/2022 2450: Post-TED Add Clarification added on when to report a COVID-19 infection:Possible Reporting Scenarios: An infection should be reported if: A recipient has a positive antibody result. They do not have a history of positive COVID diagnostic results (PCR or antigen); The recipient was symptomatic and treated, but COVID-19 diagnostic testing was not performed and / or COVID diagnostic testing was performed and negative. An infection should not be reported if: A recipient has a positive COVID diagnostic result (PCR or antigen). No treatment was given and/or recipient was asymptomatic.
4/8/2022 2450: Post-TED Add COVID-19 Reinfection blue box added in Q50 – 51: Reporting COVID-19 Reinfection There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).
4/8/2022 2450: Post-TED Add Clarification added in regard to revaccination post-infusion: Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) within the current reporting period. If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively, and continue with question 57. Revaccination Post-Infusion: When vaccines are given post-infusion, the physician should make the determination on whether the doses are part of the primary series of vaccines, third primary dose, boosters, or revaccination. If a recipient receives a new course of COVID vaccines following infusion as revaccination, report the vaccines as a new series. The most up to date CDC COVID-19 vaccine information for immunocompromised people can be found here.
4/8/2022 2450: Post-TED Add Clarification added on what to report if vaccine brand is Unknown: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify in question 92. If the vaccine brand is unknown, leave the field blank and override the error as Unknown.
4/8/2022 2400: Pre-TED Add Clarification added on what to report if vaccine brand is Unknown: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify in question 92. If the vaccine brand is unknown, leave the field blank and override the error as Unknown.
4/8/2022 2400: Pre-TED Add Reporting a COVID-19 Vaccine for Subsequent Infusions: Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) at any time prior to the start of the preparative regimen / infusion. This includes one dose without a planned second dose, first, second, and / or third dose, and a booster dose.
If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively, and continue with question 95.
If this is a subsequent infusion and all vaccine doses have already been reported on previous forms, select No and continue with question 95.
If this is a subsequent infusion and some, but not all vaccine doses have already been reported on previous forms select Yes and only report the vaccine doses not previously reported.
4/8/2022 2400: Pre-TED Add Clarification added on reporting COVID-19 infections for subsequent infusions & possible reporting scenarios: If this is a subsequent infusion and the documented COVID-19 (SARS-CoV-2) infection was already reported on previous forms, report No and continue with question 90:
Possible Reporting Scenarios: An infection should be reported if: A recipient has a positive antibody result. They do not have a history of positive COVID diagnostic results (PCR or antigen); The recipient was symptomatic and treated, but COVID-19 diagnostic testing was not performed and / or COVID diagnostic testing was performed and negative. An infection should not be reported if: A recipient has a positive COVID diagnostic result (PCR or antigen). No treatment was given and/or recipient was asymptomatic.
4/7/2022 2400: Pre-TED Add Third dose versus Booster dose blue box added above question 55 – 56 for clarification: Third dose versus Booster dose: To determine between a third dose and a booster dose, seek clinician clarification, as needed, using the guidelines listed below:
Third dose: An additional primary dose required for recipients who did not build enough protection from their primary vaccine series, typically for immunocompromised individuals
Booster dose: Administered to recipients who have enough protection after completing their primary vaccine series but then protection decreases over time
Primary vaccine series: Two doses of Pfizer-BioNTech or Moderna; One dose of Johnson & Johnson’s Janssen.
4/7/2022 2450: Post-TED Add Third dose versus Booster dose blue box added above question 55 – 56 for clarification: Third dose versus Booster dose: To determine between a third dose and a booster dose, seek clinician clarification, as needed, using the guidelines listed below:
Third dose: An additional primary dose required for recipients who did not build enough protection from their primary vaccine series, typically for immunocompromised individuals
Booster dose: Administered to recipients who have enough protection after completing their primary vaccine series but then protection decreases over time
Primary vaccine series: Two doses of Pfizer-BioNTech or Moderna; One dose of Johnson & Johnson’s Janssen.

March 2022

3/27/2022 AML Response Criteria Modify Further information added to CR to clarify CR may still be reported even if the recipient is MRD positive or the MRD status is unknown: Include recipients who are MRD positive or where the MRD status is unknown. MRD assessments includes with persistent cytogenetic, flow cytometry, and molecular methods.
3/27/2022 ALL Response Criteria Modify Further information added to CR to clarify CR may still be reported even if the recipient is MRD positive or the MRD status is unknown: Include recipients who are MRD positive or where the MRD status is unknown. MRD assessments includes with persistent cytogenetic, flow cytometry, and molecular methods.
3/27/2022 2100:Post-Infusion Follow-Up Form Remove Updated the blue box above question 131 to explain when the acute GVHD section is required to be completed:Autologous Transplants: If this was an autologous infusion or syngeneic, continue with the Infection Prophylaxis section of the form starting with question 208. Chimerism testing and graft-versus-host disease sections should only be completed for allogeneic HCTs.
3/27/2022 2100:Post-Infusion Follow-Up Form Remove Updated the blue box above question 81 to explain when the acute GVHD section is required to be completed: Autologous Transplants: If this was an autologous infusion or syngeneic, continue with the Infection Prophylaxis section. The graft-versus-host disease sections should only be completed if an allogeneic donor was used.
3/27/2022 2400: Pre-TED Remove Updated red box above question 145 for when GVHD prophylaxis questions are required to be answered: The following GVHD prophylaxis questions are to be completed for allogeneic HCTs only. Autologous and syngeneic HCTs continue with question 148.
3/27/2022 Appendix J: Reporting Comorbidities Add Update prior malignancy criteria to be consistent with Pre-TED (2400) form: Any solid tumor(s), and / or hematologic malignancy(ies), and / or skin malignancy (ies) that have been treated at any time point in the patient’s past history. A history of any benign tumor(s) should not be reported.
3/27/2022 2400: Pre-TED Add Clarified skin malignancy should be reported as a prior malignancy in question 101: Prior Malignancy, specify: Any solid tumor(s), and / or hematologic malignancy(ies), and / or skin malignancy (ies) that have been treated at any time point in the patient’s past history. A history of any benign tumor(s) should not be reported
3/24/2022 2400: Pre-TED Add COVID-19 Vaccine blue box added above question 90: COVID-19 Vaccine: If the recipient received a COVID-19 vaccine at any time prior to October 2021 (before the COVID-19 vaccine questions were available on the Pre-TED (2400) form), select Yes for question 90 at the first opportunity this form becomes available. When reporting the vaccine date, report the actual date the recipient received the vaccine.
3/24/2022 2450: Post-TED Add COVID-19 Vaccine blue box added above question 52: COVID-19 Vaccine: If the recipient received a COVID-19 vaccine at any time (including pre- or post-infusion) prior to October 2021 (before the COVID-19 vaccine questions were available on the Post-TED (2450) form), select Yes for question 52 at the first opportunity this form becomes available. When reporting the vaccine date, report the actual date the recipient received the vaccine, even if the date is outside of the reporting window or prior to infusion, override the error as Verified Correct and specify in the comments “Per CIBMTR instructions, report actual vaccine date and verify data field as correct.”

February 2022

2/28/2022 2400: Pre-TED Add Instruction added to question 22 on what to report for subject ID for recipients enrolled in the CMS studies: Enter the recipient’s USIDNET, COG, or other sponsor Subject ID. If the recipient is participating in a BMT-CTN study and the EMMES ID is known, enter it here. If the recipient is participating in an RCI-BMT study, enter the Subject ID given at the time of successful enrollment. Recipients enrolled in CIBMTR’s CMS studies should leave the subject ID blank.
2/28/2022 2402: Disease Classification Remove Removed HTB from question 257 as this no longer an option on the form with the Fall 2020 release: If the recipient’s pre-transplant disease status included hematologic improvement – erythroid, indicate the transfusion dependence at the time of determining disease status at last evaluation prior to start of the preparative regimen / infusion. Select “Non-transfused (NTD)” if the recipient was without RBC transfusions as supportive care for the disease within a period of 16 weeks prior to the start of the preparative regimen / infusion and continue with question 259. Select “Low-transfusion burden (LTB)” if the recipient had 3-7 RBC transfusions within a period of 16 weeks in at least 2 transfusion episodes with a maximum of 3 RBC transfusions in 8 weeks prior to the start of the preparative regimen / infusion and continue with question 259. Select “High-transfusion burden (HTB)” if the recipient had ≥8 RBCs transfusions within a period of 16 weeks or ≥4 within 8 weeks prior to the start of the preparative regimen / infusion and continue with question 258.
2/28/2022 2900: Recipient Death Modify Instructions for when ‘autopsy pending’ is reported were updated due to changes made during the Spring 2021 release: If Autopsy pending, continue with question 4. Report the cause of death as determined by a physician. A second Recipient Death Data (2900) form will become due six months from the date of death to report any additional cause of death information found during autopsy. the form will not go to complete (CMP) status until the autopsy results are reported. The form may be submitted with question 2 as Autopsy pending, but the form will remain in saved (SVD) status until it is updated with the results. Once the autopsy results are known, update question 2 and resubmit in order to complete the form. All pertinent causes of death should be reported on the second Recipient Death Data (2900) form.
2/28/2022 2013: CLL Pre-Infusion Modify Instructions updated for question 52 to clarify timepoint: Flow cytometry (immunophenotyping) is a technique that can be performed on blood, bone marrow, or tissue preparations where cell surface markers can be detected on cellular material. If flow cytometry (immunophenotyping) was performed at the time of diagnosis or prior to the start of therapy, report “yes” and continue with question 53. If not, report “no” and skip questions 53-60.
2/28/2022 2013: CLL Pre-Infusion Modify Instructions for question 40 updated to clarify timepoint: Indicate the leukemic cell type as either B-cell or T-cell. Cell type can be determined using immunophenotyping techniques such as flow cytometry and The cell type may be determined at any time after diagnosis and prior to HCT or cellular therapy or prior to the initiation of therapy. If the leukemic cell type was not determined at diagnosis or prior to the start of therapy, is unknown, select “unknown” and continue with question 41.
2/1/2022 2118: LYM Post-Infusion Data Modify Updated instructions to explain how to report the best response for combined follow-up scenarios; Combined follow up In scenarios where both HCT and cellular therapy forms are being completed, the best response to the current infusion (transplant or cellular therapy) should be reported. Do not report a response to a prior infusion. For scenarios where this form is completed for both the cellular therapy track and the HCT track:
Do not report a best response to the HCT on a disease form for the cellular therapy. If recipient has received a cellular therapy then an HCT, and this form is being completed for the first cellular therapy infusion, then the best response achieved will be prior to the start of preparative regimen for the subsequent HCT (or prior to the HCT if no preparative regimen is given).
Do not report a best response to the cellular therapy on a disease form for the HCT. If recipient has received an HCT then a cellular therapy, and this form is being completed for the first HCT infusion, then the best response achieved will be prior to the start of systemic therapy for the subsequent cell therapy (or prior to the CT if no systemic therapy is given).
2/1/2022 2100:Post-Infusion Follow-Up Form Modify Updated the red box above question 311 to explain when questions 311 – 315 will come due: Questions 311 – 315 The Functional Status section will only be answered on the day 100 form. Centers will not be able to complete these questions this section for any subsequent reporting periods.

January 2022

1/18/2022 Appendix J: Reporting Comorbidities Update Updated arrhythmia criteria to be consistent with the Pre-TED (2400) instructions: Any history of • Atrial fibrillation
• Atrial flutter
• Sick sinus syndrome
• Ventricular arrhythmias Any history of any type of arrhythmia that has necessitated the delivery of a specific antiarrhythmic agent. Examples include, but are not limited to, atrial fibrillation or flutter, sick sinus syndrome, and ventricular arrhythmias.
1/5/2022 ALL Response Criteria Modify Transfusion independent criteria updated for CRi: Transfusion independent (a minimum of eight weeks without platelet or red blood cell transfusion) (Please note, if the physician documents transfusion dependence related to treatment and not to the patient’s underlying AML, CR-i- should be reported
1/5/2022 AML Response Criteria Modify Transfusion independent criteria updated for CRi: Transfusion independent (a minimum of eight weeks without platelet or red blood cell transfusion) (Please note, if the physician documents transfusion dependence related to treatment and not to the patient’s underlying AML, CR-i- should be reported
Last modified: Jan 05, 2023

Need more help with this?
Don’t hesitate to contact us here.

Was this helpful?

Yes No
You indicated this topic was not helpful to you ...
Could you please leave a comment telling us why? Thank you!
Thanks for your feedback.