Q3-4: Cellular Therapy Studies

Question 3: Was the product given off label?

Commercially available CAR-T products (Breyanzi®, Kymriah®, Yescarta®) are approved for infusion based on an FDA approved label. “Off label” means use that is not consistent with the label.

Indicate if the cellular therapy product infused was given off label. This is documented in a pharmacy note, or refer to the physician.

Question 4: Total number of lines of therapy received (between diagnosis and infusion)

A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, this should be considered a new line of therapy. Additionally, if therapy is changed because a favorable disease response was not achieved, this should be considered a new line of therapy. Do not include surgery when determining the number of lines of therapy.

!Lines of therapy
Total number of lines of therapy should be reported between diagnosis and apheresis.

Report the total number of lines of therapy received since the original lymphoma diagnosis up until apheresis of the product. This is a different time point from similar questions on other forms. The intent is to know if expected number of lines of therapy per label requirements were received, and is used to determine cohort eligibility in the study.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
.	.	.	.	.

Copyright © 2004-2025 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.