Question 4: Has the recipient received a new course of cellular therapy (unplanned) since the date of the last report?
A course of cellular therapy is all infusions given for the same indication per protocol. If the recipient started a new course of cellular therapy (unplanned) that is different than the course reported on the Form 4000 corresponding to this follow up form, answer “yes” and continue with question 5.
In cases where the new course of cellular therapy is being given post-HCT and HCT follow-up forms are also being completed, and where the cellular therapy course overlaps two HCT reporting periods, the new course only needs to be reported once on the HCT follow-up forms. This applies to multiple DLI infusions that cross a reporting period.
Example 1. The new course of cellular therapy consisted of multiple infusions that happened at the end of the 6 month HCT reporting period and into the beginning of the 1 year HCT reporting period. The new course of cellular therapy should be reported only on the 6 month HCT form and not on the F4100..
- Reporting an infusion here as part of the same protocol will generate a new Form 4000. If you need help removing a Form 4000, please make sure the field is corrected and submit your request via Center Support in the ServiceNow application.
If a recipient receives two different courses of the cell therapy within the same reporting period, report the first date on this form. Then create a new indication form to report the second date, which will make a second F4000 due.
If the recipient has not received a new course of cellular therapy (unplanned) since the date of last report,
continue with question 7.
Question 5: Specify the reason for which cellular therapy was given:
If additional infusions were given for the same indication per protocol, do not report those here. Please update Form 4003 for the applicable product with the correct number of infusions given per protocol. Each infusion requires a separate Form 4006.
If the reason for the new course of cellular therapy was failure to respond or in response to disease assessment, or for a new indication, report the event date in question 6.
Question 6: Date of cellular therapy:
Report the date (YYYY-MM-DD) of the new course of cellular therapy (unplanned). If the new course of cellular therapy includes multiple infusions, the date of the first infusion should be reported here. This will require completion of a new Form 4000.
Question 7 & 8: Did the recipient receive an HCT since the date of last report?
If the recipient received an HCT since the date of the last report, report the date (YYYY-MM-DD) of HCT in question 8 and also complete CIBMTR HCT Form 2400 (Pre-Transplant Essential Data).
When regulatory requirements specify at least 15 years of follow-up data be collected on recipients of genetically modified cellular therapy products, reporting on the cellular therapy event will continue. Both HCT and cellular therapy forms will be completed.
If the recipient did not receive an HCT since the date of the last report, continue with question 9.
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