Combined follow up
In scenarios where both HCT and cellular therapy forms are being completed, duplicate questions will exist between the Cellular Therapy Essential Data Follow-Up (4100) form and the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form. To reduce the reporting burden, duplicate questions, including subsequent infusions, on the Cellular Therapy Essential Data (4100) form are disabled and will be answered on the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form.

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 this follow up form is being completed, select Yes.

If additional infusions were given for the same indication per protocol, do not report those infusions here. Update the Cellular Therapy Product (4003) form for the applicable product with the correct number of infusions given per protocol. Each infusion requires a separate Cellular Therapy Infusion (4006) form.

In cases where a new course of cellular therapy is being given post-HCT, only the first infusion is reported on the appropriate HCT follow up form (either the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form). Remaining infusions of a single course of cellular therapy (e.g. multiple DCI/DLIs) are not reported as subsequent infusions. They are captured on a single Cellular Therapy Product (4003) Form as the number of planned infusions.

Example 1. The new course of cellular therapy (post-HCT) consisting of multiple infusions started at the end of the 6- month HCT reporting period and continued into the beginning of the 1-year HCT reporting period.

How to report: The new course of cellular therapy should be reported only on the 6-month HCT follow-up form (either the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450) form) and not on the Cellular Therapy Essential Data Follow-Up (4100) form.

  • Reporting an infusion on the Cellular Therapy Essential Data Follow-Up (4100) form as a subsequent infusion will generate a new Pre-Cellular Therapy Essential Data (4000) form. If you need help removing a Pre-Cellular Therapy Essential Data (4000) form, please make sure the field is corrected and contact CIBMTR Center Support to remove the form.

Example 2. Two non-genetically modified courses of post-HCT cell therapy (e.g., DCI/DLI and MSCs) are given within 100 days of each other in the same reporting period.

How to report: Report the first course as a subsequent cellular therapy on either the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450) form. This will make a new Pre-Cellular Therapy Essential Data (4000) form due. When it is completed, report the second course of cellular therapy on the 100-day Cellular Therapy Essential Data Follow-Up (4100) form to generate the second Pre-Cellular Therapy Essential Data (4000) form.

Example 3. Two non-genetically modified courses of post-HCT (e.g., DCI/DLI and MSCs) are given greater than 100 days apart, but still within the same reporting period.

How to report: Report the first course as a subsequent cellular therapy on the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450) form. Then create a new indication form to report the second course, which will make a second Pre-Cellular Therapy Essential Data (4000) form come due.

Example 4. Two genetically modified courses of post-HCT (e.g., Kymriah and Yescarta) are given in the same reporting period.

How to report: Report the first course as a subsequent cellular therapy on the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450) form. This will make a new Pre-Cellular Therapy Essential Data (4000) form due. When it is completed, combined follow up rules will apply and both HCT and cellular therapy forms will be completed. Report the second course of cellular therapy on the 100-day Cellular Therapy Essential Data Follow-Up (4100) form to generate the second Pre-Cellular Therapy Essential Data (4000) form.

Question 5: Specify the reason for which cellular therapy was given:

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, continue with question 6 to report the event date.

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 Pre-Cellular Therapy Essential Data (4000) form.

Questions 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, select Yes and report the date (YYYY-MM-DD) of the HCT in question 8; also complete the Pre-Transplant Essential Data (2400) form.

Combined follow up
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, report No and continue with question 9.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Jan 22, 2021

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