Question 56: Specify the total number of planned infusions: (of this product) (as part of the course of cellular therapy)

Report the number of infusions specified per protocol. This question is used to make the correct number of Cellular Therapy Infusion forms (Form 4006) come due. Each infusion must be part of the protocol and will be given regardless of disease assessment.

Example 1. The protocol specifies three infusions are to be given as part of the course of cellular therapy. Report the total number of planned infusions as “3”.

Example 2. The protocol specifies five infusions are to be given as part of the course of cellular therapy. The recipient will be assessed after the first three infusions to see if additional infusions will be tolerated (not based on disease status) and two more infusions may be given. Report the total number of planned infusions as “5”. If the last two infusions do not occur, please submit a request to remove the forms via Center Support in the ServiceNow application.

Example 3. The recipient receives two DLI infusions and the notes do not specify additional infusions are to be given. Report ‘2’ and submit the form. The recipient then goes on to receive another DLI infusion for the same indication using the same donor/product. The number reported here should be updated to trigger another Form 4006 Cellular Therapy Product form.

Last modified: Jan 27, 2020

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