The sections below provide explanatory text for instructions on completing the Cellular Therapy Essential Data Pre-Infusion Form (F4000), Cellular Therapy Product Form (F4003), Cellular Therapy Infusion Form (F4006), and Cellular Therapy Essential Data Follow-Up Form (F4100).
Below are the scenarios describing when autologous cellular therapy data can be collected in the context of patient consent for research:
Reporting of commercial products infusions (i.e. Kymriah, Yescarta) is strongly encouraged.
1. Autologous cellular therapy: 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 should not be reported to the CIBMTR. In these cases, please make sure that the patient consents for data sharing with the CIBMTR before assigning a CRID.
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 required to be retroactively reported.
2. Autologous cellular therapy given after HCT: for any cellular therapy infusion (e.g. co-infusion, DLI/DCI, CAR-T) given after a patient has already had an HCT, please follow the table below for requirements:
|First infusion type||Consent for research is obtained for HCT||Second infusion type||Consent for research is obtained for CT||Report that the CT event occurred?||Complete the F4000 series?||How to report|
|Auto HCT||Yes||Auto cellular therapy||Yes / Not Approached (prior consent status is valid)||Yes||Voluntary form completion||CT infusion reported on appropriate HCT follow up form to trigger F4000|
|Auto HCT||Yes||Auto cellular therapy||Declined||Yes||No||CT infusion reported on the appropriate HCT form as occurring but F4000 would be made NRQ|
|Auto HCT||No||Auto cellular therapy||Yes||Yes||Voluntary form completion||Would create new F2814 Indication form to trigger F4000|
|Auto HCT||No||Auto cellular therapy||No / Not approached||No||No||Do not report to CIBMTR|
|Allo HCT||Yes||Auto cellular therapy||Yes / Not approached||yes||Voluntary form completion or *limited data collection||CT infusion reported on appropriate HCT follow up form to trigger F4000|
|Allo HCT||Yes||Auto cellular therapy||Declined||yes||*limited data collection||The CT is reported on the HCT form as occurring, but the CT forms would be abbreviated|
|Allo HCT||No||Auto cellular therapy||Yes||yes||Voluntary form completion or *limited data collection||CT infusion reported on appropriate HCT follow up form to trigger F4000|
|Allo HCT||No||Auto cellular therapy||No / Not approached||yes||*limited data collection||The CT is reported on the HCT form as occurring, but the CT forms would be abbreviated|
*limited data collection form in progress
What infusions can be classified as a “DCI”?
An infusion can be classified as a “DCI” when:
- The intent is something other than to restore hematopoiesis
- The infusion must be post-HCT, often by the same donor as the HCT
- Indication is suboptimal donor chimerism, immune reconstitution, GVHD treatment, prevent or treat disease relapse (as reported on F4000)
- Composition of cells include un-manipulated lymphocytes, mesenchymal cells, peripheral blood mononuclear cells, NK cells, etc.
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