Cell Therapy Reporting Tracks and Follow-Up Schedules

Beginning in July of 2023, a reporting track will now be set for all cell therapy CRIDs reported to CIBMTR. The track will be set by the center reporting preference and infusion type.

*TED vs CRF reporting for cellular therapy was launched in the Summer 2023 release. It is determined by the center reporting preference and infusion details; it is not a center level attribute like HCT reporting.

There are five cellular therapy reporting tracks.

15 Year Follow-Up (CRF)

• Applies to commercially available CAR-T PASS studies currently accruing, BMT CTN studies, genetically modified products (other than CAR-T) either stand alone or post-HCT, and registry partners
• Follow-up schedule: 100 day – 15 years
• Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable)
  

Standard Follow-Up (TED)

• Applies to commercially available CAR-T PASS studies that are currently accruing but CIBMTR research database consent is not obtained, commercially available CAR-T products no longer part of a PASS study, non-commercial CAR-T products, and stand-alone non-genetically modified cell therapy infusions without a history of HCT
• Follow-up schedule: 100d – 6yr, 8yr, 10yr, 12yr, 14yr
• Forms: F4000, F4003, F4006, F4100, F2402
  

100-Day Only Follow-Up

• Applies to post-HCT non-genetically modified cell therapy infusions (excludes Donor Lymphocyte Infusions (DLIs))
• Follow-up schedule: 100-day only
• Forms: F4000, F4003, F4006, single F4100 at 100d, F2402 + disease forms (when applicable)
  

CTRM

• Applies to cell therapy infusions for regenerative medicine indications (cardiovascular disease, musculoskeletal disorder, neurologic disease, ocular disease, pulmonary disease) and genetically modified cellular therapy products (not CAR-T) when the center reporting preference is Do not perform/Perform do not report/Research
• Follow-up schedule: None
• Forms: F4000, F4003, F4006
  

No Follow-Up

• Applies when consent to CIBMTR Research Database has not been obtained for commercially available CAR-T products no longer part of a PASS study, other genetically modified cellular therapy products, and non-genetically modified cellular therapy products
• Follow-up schedule: None
• Forms: F4000 + F2402
  

TED (Standard & 100-Day Only)	CRF (15 years)	CTRM	No Follow-Up
Commercial CAR-T on study, no consent, REMS/RGL center (Standard Follow-Up TED)	Commercial CAR-T on study (15 years)	Indication = Cardiovascular disease, Musculoskeletal disorder, Neurologic disease, Ocular disease, Pulmonary disease	Commercially available CAR-T products no longer part of a PASS study without consent
Commercial CAR-T not on study (Standard Follow-Up TED)	BMT CTN	Non-commercial genetically modified non-CAR-T products	Genetically modified cellular therapy products other than CAR-T
Non-commercial CAR-T products (Standard Follow-Up TED)	Genetically modified products (other than CAR-T) either stand alone or post-HCT		Non-genetically modified cellular therapy products
Stand-alone non-genetically modified cell therapy infusions without a history of HCT (Standard Follow-Up TED)	Commercial CAR-T not on study (Standard Follow-Up CRF)
Post-HCT non-genetically modified cell therapy infusions (100 day only)

Commercial CAR-T = Kymriah®, Yescarta®, Tecartus^TM, Abecma®, Breyanzi^TM, Carvykti^TM

If forms did not come due as expected, or you have questions on the forms that did come due, please submit a ticket via CIBMTR Center Support.

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