Cellular Therapy Manuals

The sections below provide instructions for 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 scenarios describing when autologous cellular therapy data can be collected in the context of patient consent for research:
Reporting of commercially available cellular therapy product infusions (i.e. Kymriah®, Yescarta^TM, Tecartus^TM, Breyanzi^TM, Abecma®) is strongly encouraged.

1. Autologous cellular therapy: 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.

REMS reporting: infusions can be reported without research consent if the center is utilizing CIBMTR to support their REMS reporting needs in meeting the requirements for the commercially available CAR-T products.

2. Autologous cellular therapy given after HCT: Any cellular therapy infusion (e.g. co-infusion, DLI/DCI, CAR-T) given after a patient had a prior 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	CT infusion reported on appropriate HCT follow up form to trigger F4000
Allo HCT	Yes	Auto cellular therapy	Declined	yes	Voluntary form completion	CT infusion reported on appropriate HCT follow up form to trigger F4000 but F4000 would be made NRQ
Allo HCT	No	Auto cellular therapy	Yes	yes	Voluntary form completion	CT infusion reported on appropriate HCT follow up form to trigger F4000
Allo HCT	No	Auto cellular therapy	No / Not approached	yes	Voluntary form completion	CT infusion reported on appropriate HCT follow up form to trigger F4000 but F4000 would be made NRQ

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

Date	Manual Section	Add/Remove/Modify	Description	Reasoning (If applicable)
9/15/2021	Cellular Therapy Manuals	Add	Added: REMS reporting: infusions can be reported without research consent if the center is utilizing CIBMTR to support their REMS reporting needs in meeting the requirements for the commercially available CAR-T products.	Centers can use CIBMTR to support REMS reporting requirements.

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CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®/Be The Match® and the Medical College of Wisconsin