Q5-10: Lymphodepleting Therapy Prior to Cellular Therapy

*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.

Question 5: Height at start of lymphodepleting therapy:

Report the recipient’s actual height just prior to the start of the lymphodepleting therapy. The intent of this question is to determine the height used when calculating lymphodepleting therapy drug doses. This height is usually documented on the infusion orders or admitting orders. Report height to the nearest whole centimeter or inch (round up if 0.5 or greater).

Question 6: Weight at start of lymphodepleting therapy:

Report the recipient’s actual body weight just prior to the start of the lymphodepleting therapy. The intent of this question is to report the actual weight at the time the lymphodepleting therapy starts (which may be different than the weight used to determine lymphodepleting therapy doses). This weight is usually documented on the infusion orders or admitting orders. Report weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight.

Questions 7-8: Specify lymphodepleting drugs

The form lists each drug by the generic name.

For each lymphodepleting drug administered, check the box to indicate the drug was given as part of the lymphodepleting therapy used prior to the cellular therapy infusion.

Select Other drug and specify the drug name in question 8 only if the lymphodepleting drug is not listed as an option. If more than one “other” drug is prescribed, each “other” drug should be reported in a separate instance. List the generic name of the drug in the space provided and attach a copy of the source document using the attachment feature in FormsNet3^SM.

Question 9: Total prescribed dose:

Report the total prescribed dose of each drug in mg/m² as stated in the protocol. Do not report the prescribed daily dose. Report the drug doses to the nearest tenth.

Question 10: Date started:

Report the date (YYYY-MM-DD) the drug was first administered. If the exact date is unknown, review the General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

*Copy and complete Specify lymphodepleting drugs, total prescribed dose, and Date started to report all drugs given as lymphodepleting therapy.

Section Updates:

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