Cell therapy reporting preferences took effect in July 2022 and are used to determine how forms come due.
Do Not Perform
Site does not perform any cell therapy infusions, only HCT
- Other types of Donor Cellular Infusion (DCIs), but excluding DLIs, should be considered as cell therapy infusions
- Note: This status will not prevent cell therapy forms from being made due if a cell therapy infusion is reported. If a cell therapy infusion is reported, rules for the research level will be followed.
Perform Do Not Report
Site is performing cell therapies (i.e. CAR-T, VSTs, CTLs, DCIs), but no infusions are submitted to CIBMTR
- Other types of Donor Cellular Infusion (DCIs), but excluding DLIs, should be considered as cellular therapy infusions
- Note: This status will not prevent cell therapy forms from being made due if a cell therapy infusion is reported. If a cell therapy infusion is reported, rules for the research level will be followed.
Research Level
All TYPES of cell therapy infusions that are performed at the site can be submitted to CIBMTR
- This includes all commercially available products, investigator studies, and clinical trial infusions
- CIBMTR has an embargo request for clinical trial and study data. A job aid is available on the CIBMTR Portal.
CIBMTR Research Database consent status will be considered for determining what forms come due:
- If CIBMTR Research Database consent is ‘yes’, then all forms come due as expected
- If CIBMTR Research Database consent is ‘no’, then only the F4000/2402 will come due
REMS Level
ONLY commercially available cell therapy product infusions are submitted to CIBMTR
- Examples include Kymriah®, Yescarta®, Tecartus®, Breyanzi®, Abecma®, Carvykti®
For the commercially available products, all forms, including 15 years of follow-up, come due as expected regardless of consent status.
- If CIBMTR Research Database consent is ‘yes’, then all forms come due as expected
- If CIBMTR Research Database consent is ‘no’, then all forms come due on standard follow-up (TED) schedule
Data are made available in the DBtC application CT REMS report to support a centers REMS reporting needs in meeting the requirements for the commercially available CAR-T products. This tool provides the data in the appropriate format for REMS submission by the center. These data will not be used for research.
This status will not prevent forms from being made due for non-commercially available products.
- If non-commercially available products are reported, CIBMTR Research Database consent status will be considered for determining what forms come due
- If CIBMTR Research Database consent is ‘yes’, then all forms come due as expected
- If CIBMTR Research Database consent is ‘no’, then only the F4000/2402 will come due
If you would like to change the cell therapy reporting preference for your center or have questions about which reporting preference has been chosen, please submit a ticket via CIBMTR Center Support.