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.
There are five cellular therapy reporting follow-up schedules. The follow-up schedule can be determined by either Pre-CTED (4000) Form or Cellular Therapy Product (4003) Form.
Missing Follow-Up Forms
If the Pre-CTED (4000) Form is completed and only the Cellular Therapy Product (4003) Form has come due, the Form 4003 is required to determine the follow-up schedule.
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
- Follow-up schedule set by F4000 OR F4003
- Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), 3500 + 3501 (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 (REMS center reporting preference), 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
- Follow-up schedule set by F4000 OR F4003
- Forms: F4000, F4003, F4006, F4100, F2402, 3500 (when applicable)
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
- Follow-up schedule set by F4000
- Forms: F4000, F4003, F4006, single F4100 at 100d, F2402, 3500 (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
- Follow-up schedule set by F4000 OR F4003
- 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
- Follow-up schedule set by F4000 OR F4003
- Forms: F4000 + F2402
| TED (Standard & 100-Day Only) | CRF (15 years) | CTRM | No Follow-Up |
|---|---|---|---|
| Commercial CAR-T no consent, REMS center (Standard Follow-Up TED) | Commercial CAR-T on study (15 years) | Indication = Cardiovascular disease, Musculoskeletal disorder, Neurologic disease, Ocular disease, Pulmonary disease | Commercial CAR-T, no consent (cannot be on study), Research center |
| 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, no consent |
| 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, no consent | |
| 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®, Abecma®, Breyanzi®, Carvykti®
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.