Q73: Lymphodepleting Therapy Prior to Cellular Therapy

*Lymphodepleting therapy data collection has been split between TED and CRF level reporting. TED level reporting will capture just Yes or No if lymphodepleting therapy was given. All details will be capture on the Pre-Cellular Therapy Baseline Data (4001) form if the infusion is selected for CRF level reporting.

Question 73: Was lymphodepleting therapy given prior to the infusion? (does not include lines of therapy given for disease treatment, bridging therapy, or maintenance)

Lymphodepleting therapy is given to destroy lymphocytes (e.g., T cells). Indicate Yes or No if the lymphodepleting therapy was given prior to the infusion. Do not include therapy given to treat disease – this therapy should be reported on the disease specific form, if applicable.

*Bridging therapy is a new terminology and is defined as any treatment that is given after the leukapheresis, during the period of cell manufacturing, with the goal of controlling the disease until the cellular product is ready to be infused. Do not report bridging therapy in this section. Bridging therapy, therapy given after leukapheresis up until the initiation of lymphodepleting chemotherapy for the purpose of disease control or management, should be reported on the disease specific form as a line of therapy, if applicable.

Section Updates:

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