Q47: Product Infusion

Question 47: Specify the total number of planned infusions of this product: (as part of the course of cellular therapy)

Report the number of infusions specified per protocol. This question is used to make the correct number of Cellular Therapy Infusion (4006) forms come due. Each infusion must be part of the protocol and will be given regardless of disease assessment.

*For infusions of Breyanzi^TM (both commercially available and non-conforming products), which has both CD4+ and CD8+ components, report as a single infusion and complete a single Infusion Form 4006.

Example 1. The protocol specifies three infusions are to be given as part of the course of cellular therapy. Report the total number of planned infusions as “3”.

Example 2. The protocol specifies five infusions are to be given as part of the course of cellular therapy. The recipient will be assessed after the first three infusions to see if additional infusions will be tolerated (not based on disease status) and two more infusions may be given. Report the total number of planned infusions as “5”. If the last two infusions do not occur, submit a request to remove the forms via Center Support in the ServiceNow application.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
47	7/29/2022	Remove	Removed Example 3: The recipient receives two DLI infusions and the notes do not specify additional infusions are to be given. Report ‘2’ and submit the form. The recipient then goes on to receive another DLI infusion for the same indication using the same donor / product. The number reported here should be updated to trigger another Cellular Therapy Infusion (4006) form.	DLIs are no longer reported on the F4003.

Copyright © 2004-2024 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.