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 cell 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 products part of a PASS study and consent is yes
- BMT CTN studies
- Follow-up schedule: 100 day – 15 years
- Follow-up schedule set by F4000
- Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), F3500 + F3501 (when applicable)
Standard Follow-Up (CRF)
- Applies to a portion of commercially available products after PASS study accrual has been met and consent is yes
- Follow-up schedule: 100d – 6yr, 8yr, 10yr, 12yr, 14yr
- Follow-up schedule set by F4000 OR F2402
- Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), F3500 + F3501 (when applicable)
Standard Follow-Up (TED)
- Applies to:
- commercially available products no longer part of a PASS study and consent is yes
- non-commercial CAR-T products
- 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 (when applicable), 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 (when applicable), F3500 (when applicable)
CTRM
- Applies to cell therapy infusions for regenerative medicine indications (cardiovascular disease, musculoskeletal disorder, neurologic disease, ocular disease, pulmonary disease)
- Follow-up schedule: None
- Follow-up schedule set by F4000
- Forms: F4000, F4003, F4006
No Follow-Up
- Applies to when consent to CIBMTR Research Database has not been obtained
- Follow-up schedule: None
- Follow-up schedule set by F4000 OR F4003
- Forms: F4000 + F2402
| TED (Standard & 100-Day Only) | CRF (Standard Follow-Up CRF &15 years) | CTRM | No Follow-Up |
|---|---|---|---|
| Commercial product not on study (Standard Follow-Up TED) | Commercial CAR-T on study (15 years) | Indication = Cardiovascular disease, Musculoskeletal disorder, Neurologic disease, Ocular disease, Pulmonary disease | Consent to CIBMTR Research Database has not been obtained |
| Non-commercial CAR-T products (Standard Follow-Up TED) | BMT CTN | ||
| Stand-alone non-genetically modified cell therapy infusions without a history of HCT (Standard Follow-Up TED) | Portion of commercial CAR-T not on study (Standard Follow-Up CRF) | ||
| Post-HCT non-genetically modified cell therapy infusions (100 day only) |
Commercial products = Kymriah®, Yescarta®, Tecartus®, Abecma®, Breyanzi®, Carvykti®, Tecelra®, Amtagvi®
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.