Cellular Therapy Manuals

This section provides explanatory text for each question on the Pre-CTED, Pre-CTED Baseline, Cellular Therapy Product, Cellular Therapy Infusion, Post-CTED, and Post-CTED Follow-up forms.

4000: Cellular Therapy Essential Data Pre-Infusion
4001: Pre-Cellular Therapy Baseline Data
4003: Cellular Therapy Product
4006: Cellular Therapy Infusion
4100: Cellular Therapy Essential Data Follow-Up
4101: Post-Cellular Therapy Follow-Up

*Reporting of cellular therapy infusions to CIBMTR remains voluntary. Reporting of commercially available cellular therapy product infusions (i.e. Kymriah®, Yescarta^TM, Tecartus^TM, Breyanzi^TM, Abecma®, Carvykti^TM) is strongly encouraged.

Cell therapy reporting tracks and follow up schedule
Beginning Summer 2022 and updated in Summer 2023, a reporting track is set for all cell therapy infusions reported to the CIBMTR. The track will be set by the center reporting preference and infusion details and will determine which forms come due. There are five cellular therapy reporting tracks:

• 15 years (CRF)
  • Forms: 4000, 4001, 4003, 4006, 4100, 4101, 2402 + disease forms (when applicable)

• Standard follow up TED
  • Forms: 4000, 4003, 4006, 4100, 2402

• 100 day only (TED)
  • Forms: 4000, 4003, 4006, single 4100 at 100d, 2402

• CTRM
  • Forms: 4000, 4003, 4006

• No follow up
  • Forms: 4000, 2402

See the Data Management Guide for a full description of each track and follow up schedule.

Cell therapy reporting preferences:
As part of the Summer 2022 release, every center will have a reporting preference. The options are:

• Do Not Perform
• Perform Do Not Report
• Research Level
• Regulatory Level
  

Please see the Data Management Guide for a full description of the different levels, including which forms will come due.

Follow up tracks as set by reporting preference
As part of the Summer 2022 release, the center reporting preference is now used in determining the cell therapy reporting track, and subsequently which forms are required.

TED (Standard & 100 day only)	CRF (15 years)	CTRM
Commercial CAR-T on study, no consent, REMS/RGL center (Standard follow up TED)	Commercial CAR-T on study (15 years)	_Indication = Cardiovascular disease, Musculoskeletal disorder, Neurologic disease, Ocular disease, Pulmonary disease
Commercial CAR-T not on study (Standard follow up TED)	BMT CTN (15 years)	Non-commercial genetically modified non-CAR-T products
Non-commercial CAR-T products (Standard follow up TED)	Genetically modified products (other than CAR-T) either stand alone or post-HCT (15 years)
Stand-alone non-genetically modified cell therapy infusions without a history of HCT (Standard follow up TED)	Commercial CAR-T not on study (Standard follow up CRF)
Post-HCT non-genetically modified cell therapy infusions (100 day only)	Registry Partners

Commercial CAR-T = Kymriah®, Yescarta®, Tecartus^TM, Abecma®, Breyanzi^TM, Carvykti^TM

When to report cellular therapy infusions to the CIBMTR

Please see the Data Management Guide for a full description the guidance when determining whether to report a cellular therapy to the CIBMTR.

Donor cellular infusion (DCI)
Donor cellular infusions (DCIs) are a subtype of cellular therapy.

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 mesenchymal cells, peripheral blood mononuclear cells, NK cells, etc.
  

Donor Lymphocyte Infusions (DLIs) are a subset of DCIs. DLIs meet the same criteria above but are infusions of just a lymphocyte product. DLIs are reported on the Donor Lymphocyte Infusion (2199) form. See the F2199 manual for the definition of DLI.

Date	Manual Section	Add/Remove/Modify	Description
5/3/2024	Cellular Therapy Manuals	Modify	Reformatted and added hyperlinks to the cellular therapy manuals contained in this section.
7/28/2023	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Version 10 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 10 corresponds to revision 10 of the Form 4000.
7/28/2023	4001: Pre-Cellular Therapy Baseline Data	Add	Version 1 of the 4001: Pre-Cellular Therapy Baseline Data section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the form 4001.
7/28/2023	4100: Cellular Therapy Essential Data Follow-Up	Add	Version 9 of the 4100: Post- Cellular Therapy Follow-Up section of the Forms Instruction Manual released. Version 9 corresponds to revision 9 of the form 4100.
7/28/2023	4101: Post-Cellular Therapy Follow-Up	Add	Version 1 of the 4101: Post- Cellular Therapy Follow-Up section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the form 4101.
2/8/23	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated the text in the blue box below question 121: Serologic tests should be completed during the pre-HCT work-up phase, or approximately one month prior to the start of the preparative regimen. If a recipient tests positive for Hepatitis B core antibody (Anti HBc), Hepatitis B surface antigen (HBsAg), Hepatitis B NAAT, Hepatitis C antibody (Anti HCV), and/or Hepatitis C NAAT serologic tests, also complete the HEP Form (Form 2047). If a recipient tests positive for HIV antibody or HIV NAT serologic tests, also complete the HIV Form (Form 2048).
9/23/2022	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Version 9 of the Cellular Therapy Manuals section of the Forms Instruction Manual released.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.