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 are determined by infusion details reported on Pre-CTED (4000), and/or Disease Classification (2402), and/or Recipient Eligibility (2500) form. See tables below for expected follow up schedules and detailed descriptions.
| Form | Scenario | Follow up schedule |
|---|---|---|
| 4000 | Indication is Cardiovascular disease, Musculoskeletal disorder, Neurologic disease, Ocular disease, or Pulmonary disease | CTRM |
| BMT CTN study was selected as the study sponsor | 15 Year Follow-Up (CRF) | |
| Research database consent is No | No Follow-Up | |
| Non-conforming product (NCP) Breyanzi or Abecma enrolled onto CIBMTR Study CS20-36 | 15 Year Follow-Up (CRF) | |
| NCP Breyanzi or Abecma NOT enrolled onto CIBMTR Study CS20-36 | Standard Follow-Up (TED) | |
| Infusion is a standalone non-genetically modified cellular therapy infusion | Standard Follow-Up (TED) | |
| Infusion is post-HCT and non-genetically modified | 100-Day Only Follow-Up |
If no follow-up forms come due after completing the F4000, then you must complete the F2402.
| Form | Scenario | Follow up schedule |
|---|---|---|
| 2402 | Product name is Anitocabtagene autoleucel, Arlocabtagene autoleucel, Brexucabtagene autoleucel (Tecartus®), Ciltacabtagene autoleucel (Carvykti®), Idecabtagene vicleucel (Abecma®), Letetresgene autoleucel, Lifileucel (Amtagvi®), Rapcabtagene autoleucel, Relmacabtagene autocel (Carteyva®), , Tabelecleucel (EbvalloTM), Zamtocabtagene autocel, Zevorcabtagene autoleucel | Standard Follow-Up (TED) |
| Aucatzyl®, Breyanzi®, Kymriah®, Tecelra®, Yescarta®, NOT enrolled onto study | Standard Follow-Up (TED) |
If no follow-up forms come due after completing the F2402, then you must complete the F2500.
| Form | Scenario | Follow up schedule |
|---|---|---|
| 2500 | Aucatzyl®, Breyanzi®, Kymriah®, Tecelra®, Yescarta®, enrolled onto study | 15 Year Follow-Up (CRF) |
| Aucatzyl®, Breyanzi®, Kymriah®, Tecelra®, Yescarta®, NOT enrolled onto study | Standard Follow-Up (TED) |
If no follow-up forms come due after completing the F2402, submit a ticket via CIBMTR Center Support.
Descriptions
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 or F2500
- Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), F3500 + F3501 (when applicable), F2900
Standard Follow-Up (CRF) Not currently active
- 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 n/a
- Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), F3500 + F3501 (when applicable), F2900
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 F2402 or F2500
- 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
- Forms: F4000 + F2402
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.