Please consider the following guidance when determining whether to report a cellular therapy to the CIBMTR. The scope of this document covers autologous cellular therapies only.
Reporting autologous cellular therapy data to the CIBMTR
Reporting of autologous cellular therapy data to the CIBMTR remains voluntary at this time, with the exception of cellular therapy received after an allogeneic HCT. Reporting of the infusion date is strongly encouraged and form completion remains voluntary.
Consent status for Cellular Therapy
The CIBMTR encourages centers to approach all patients for consent to participate in the Observational Research Database. When a patient consents to participate in the Observational Database, their data are stored in the CIBMTR’s Observational Research Database and may be used for research. The primary purpose of the Observational Research Database is to have a comprehensive source of data that can be used to study cellular therapy and hematopoietic cellular transplantation (HCT). The consent form applies to both HCT and cellular therapy. Per CIBMTR, a patient only needs to be consented once to participate in the Observational Research Database, however, you should follow the guidance of your local IRB. The most recent consent status reported to CIBMTR is the consent applied to the entire patient record.
Below are the scenarios describing when autologous cellular therapy data can be collected in the context of patient consent for research:
- : For any cellular therapy (e.g., CAR T-cells) that uses an autologous donor/product and is given as a stand-alone therapy (not associated with an HCT)
- Reporting these infusions is voluntary at this time. When consent for research is not obtained, these infusions can be reported to the CIBMTR, but there will be limited data collection.
- If consent for research is later obtained for a subsequent infusion, cellular therapy infusions that occurred prior to obtaining consent to participate in the Observational Database are not be required to be retroactively reported.
- CT REMS report tool: infusions can be reported without research consent if the center is utilizing CIBMTR’s CT REMS report to support their 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.
- : for any cellular therapy infusion (e.g. co-infusion, DCI, CAR-T) given after a patient has already had an HCT, please follow the table below for requirements: