This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT “DCI / DLI” infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form.
The Post-Cellular Therapy Essential Data (Post-CTED) follow-up form focuses on key follow-up information for each reporting period, including the survival status of the recipient, causes of death if the recipient died in the period since the last report, additional cellular infusions performed, response to the cellular therapy, relapse, current hematologic findings, development of new malignancies, persistence of the cellular product (product specific), development and severity of toxicities (e.g. cytokine release syndrome, neurotoxicity), infection and fertility information.
The Post-CTED Form must be completed at the following time points post-cellular therapy: 100 days, six months, and annually thereafter. The follow-up reporting schedule is determined by whether the product is genetically modified or not. The structure of the Post-CTED is such that each form should fit on a timeline with distinct start and stop dates that do not overlap any other forms.
Combined follow up
In scenarios where both HCT and cellular therapy forms are being completed, there are two scenarios where the Cellular Therapy Essential Data Follow-Up (4100) form is completed:
Example 1. Cellular therapy after HCT: completion of this form should be based on the time period in relation to the CT infusion date (i.e. 100 days after the CT infusion date). The visit ID should match between the corresponding Post-HSCT Data (2100) or Post-Transplant Essential Data (2450).
Example 2. HCT after cellular therapy: completion of this form should be based on the time period in relation to the HCT infusion date (i.e. 100 days after the HCT infusion date). The visit ID should match between the corresponding Post-HSCT Data (2100) or Post-Transplant Essential Data (2450).
Duplicate questions between HCT and cellular therapy forms may be disabled on the Post-CTED. A full list of enabled/disabled fields can be found on the “Subsequent Infusions – Updates to Follow-Up Reporting section of the Data Management Guide. Illustrations of the combined follow up scenarios can also be found the Guide.
Q4-8: Subsequent Cellular Infusions
Q9-11: Best Response to Cellular Therapy
Q12-20: Peripheral Blood Count Recovery
Q21-22: Disease Relapse or Progression
Q23-33: Current Hematologic Findings
Q34: New Malignancy, Lymphoproliferative or Myeloproliferative Disease/Disorder
Q35-59: Persistence of Cells
Q60-79: Graft vs. Host Disease
Q176-177: Pregnancy Status
Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|1/22/2021||4100: Cellular Therapy Essential Data Follow-Up||Modify||Version 6 section of the Forms Instruction Manual released. Version 6 corresponds to revision 6 of the Form 4100.|
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