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.

3500: Subsequent Neoplasms
4000: Cellular Therapy Essential Data Pre-Infusion
4003: Cellular Therapy Product
4006: Cellular Therapy Infusion
4100: Cellular Therapy Essential Data Follow-Up

Last modified: Mar 02, 2020

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