Q92-98: Lymphodepleting Therapy Prior to Cellular Therapy

Question 92: 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 report in this section any holding / bridging therapy or therapy given to treat disease. Holding / bridging therapy is captured in the section above. Any therapy with the purpose of disease control or management should be reported on the disease specific form as a line of therapy, if applicable.

Question 93: 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 94: Actual weight at start of lymphodepleting therapy

Report the recipient’s actual body weight just prior to the start of the preparative regimen. The intent of this question is to capture the recipient’s most recent (actual) weight prior to the start of the preparative regimen (or infusion if a preparative regimen was not given). Report the weight using the admission records and / or vitals. If the weight was assessed multiple times prior to the start of the preparative regimen (or infusion), report the most recent weight.

Report the weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight.

*Reporting Multiple Lymphodepleting Drugs
Copy and complete Specify lymphodepleting drugs, Total prescribed dose, and Date started to report all drugs given as lymphodepleting therapy.

Questions 95-96: 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 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 97: Total prescribed dose

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

Question 98: Date started

Report the date the drug was first administered.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Section Updates:

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