Question 78: 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.
Question 79: 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.
Question 80: Height at start of lymphodepleting therapy:
Report the recipient’s 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).
Questions 81 – 82: 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 82 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 FormsNet3SM.
Question 83: 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 84: 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.
|Question Number||Date of Change||Add/Remove/Modify||Description||Reasoning (If applicable)|
Need more help with this?
Don’t hesitate to contact us here.