Cell therapy reporting preferences will take effect in July 2022 and will be used to determine how forms come due.
Do Not Perform
Site does not perform any cellular therapy infusions, only HCT
- Other types of Donor Cellular Infusion (DCIs), but excluding DLIs, should be considered as cellular therapy infusions.
- Note: This status will not prevent cellular therapy forms from being made due if a cellular therapy infusion is reported. If a cellular therapy infusion is reported, rules for the Research level will be followed.
Perform Do Not Report
Site is performing cellular therapies (i.e. CAR-T, VSTs, CTLs, DCI), 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 cellular therapy infusion is reported. If a cellular therapy infusion is reported, rules for the Research level will be followed.
Research Level
All TYPES of cellular therapy infusions that are performed at the site are submitted to CIBMTR
- This includes all commercially available products, investigator studies, and clinical trial infusions
- CIBMTR is working on an embargo process for clinical trial and study data. More information will be sent at a later date
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
Regulatory Level
ONLY Commercially available cellular 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.
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 cellular therapy reporting preference for your center or have questions about which reporting preference has been chosen, please submit a ticket via CIBMTR Center Support.