4006: Cellular Therapy Infusion

This form must be completed for all infusions for recipients of non-HCT cellular therapy (including post-HCT “DCI / DLI” infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) form.

The Cellular Therapy Infusion (4006) form is designed to capture infusion-specific information for all infusions given to a recipient as part of a course of cellular therapy. In addition to use in research, this information is used for quality assurance measures, both by the NMDP and the Cord Blood Banks.

Product specific information is collected on Cellular Therapy Product (4003) form. A Cellular Therapy Product (4003) form is required for each product and a Cellular Therapy Infusion (4006) form is required for each infusion of that product. For example, a single product may be infused three times per course of cellular therapy. In this scenario, one Cellular Therapy Product (4003) form and three Cellular Therapy Infusion (4006) forms would be completed.

If more than one infusion occurs, as defined by event date, each infusion must be analyzed and reported on a separate Cellular Therapy Product (4006) form. This is true even if the same product is being infused on a later date.

For more information see Appendix D–How to Distinguish Infusion Types and Appendix E–Definition of a Product.

Links to sections of form:
Q1-31: Product Infusion
Q32-35: Concomitant Therapy

Date	Manual Section	Add/Remove/Modify	Description
12/12/23	Q32-35: Concomitant Therapy	Modify	Updated the definition of concomitant therapy: Concomitant therapy is any therapy given to increase the effectiveness of the cellular therapy or decrease the toxicity enhance the function of the cellular therapy
7/26/2023	Q1-31: Product Identification	Add	New note box for Abecma® ] under Lot number: If the cellular therapy product infused is the commercially available product Abecma®, the lot number must be reported and is available on the Release for Infusion (RFI).
7/26/2023	Q1-31: Product Identification	Modify	Added Abecma® and BreyanziTM to the blue note box under Batch number: If the cellular therapy product infused is the commercially available product Yescarta®, Tecartus®, Abecma®, or BreyanziTM do not report a batch number.
10/27/2022	Q1-31: Product Identification	Modify	Added CarvyktiTM to the blue note box above below14: If the cellular therapy product infused is the commercially available product Kymriah® ,or BreyanziTM, Abecma®, or CarvyktiTM this question will be disabled.
9/29/2021	Q1-31: Product Identification	Modify	Added CarvyktiTM to the blue note box above question 14: Product specific reporting guides for reporting cells administered can be requested for Kymriah®, BreyanziTM, Abecma®, and CarvyktiTM by contacting CIBMTR Center Support.
9/23/2022	4006: Cellular Therapy Infusion	Modify	Updated for new DLI reporting process: This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT DCI /DLI” infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) form. For recipients of Donor Lymphocyte Infusions (DLI), complete the Donor Lymphocyte Infusion (2199) form.
9/23/2022	4006: Cellular Therapy Infusion	Remove	Removed blue note box below question 1: If your center considers this to be a Donor Lymphocyte Infusions (DLI), as reported on the Pre-CTED (4000) form, product name will not be auto-populated. Select Other product for the product name
9/23/2022	4006: Cellular Therapy Infusion	Modify	Added commercially available CAR-T product CarvyktiTM to the blue note box below Batch number in question 2-5: If the cellular therapy product infused is the commercially available product Kymriah® or CarvyktiTM, the batch number must be reported and is available with the information that comes with the product.
9/23/2022	4006: Cellular Therapy Infusion	Modify	Removed the reference to DLI: If the product being infused as a cellular therapy is a portion from a prior HCT (e.g., DLI/ DCI), the portion becomes the “entire” product for the purposes of this form.
9/23/2022	4006: Cellular Therapy Infusion	Modify	Added commercially available CAR-T product CarvyktiTM to the blue note box below question 10-13: If the cellular therapy product infused is the commercially available product Kymriah®, Yescarta®, TecartusTM, BreyanziTM, or Abecma®, or CarvyktiTM report the route of infusion as Intravenous.
5/10/2022	4006: Cellular Therapy Infusion	Modify	Removed Breyanzi from the blue note box below question 14: If the cellular therapy product infused is the commercially available product Kymriah® , BreyanziTM, or Abemca®, this question will be disabled.
1/28/2022	4006: Cellular Therapy Infusion	Modify	Version 6 of the 4006: Cellular Therapy Infusion section of the Forms Instruction Manual released. Version 6 corresponds to revision 6 of the Form 4006.

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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.