4101: Post-Cellular Therapy Follow-Up

This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT DCI infusions selected for CRF level reporting. It will be completed in conjunction with the Cellular Therapy Essential Data Follow-Up (4100) form. For more information on TED and CRF level reporting is available in Data Management Guide, Cell therapy reporting tracks and follow up schedules.

For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form. For recipients of Donor Lymphocyte Infusions (DLI), complete the Donor Lymphocyte Infusion (2199) form

The Post-Cellular Therapy Follow up Form focuses on research level data for each reporting period, including post-infusion hospital admission, antigen escape, current hematologic findings, and persistence of the cellular product. The structure of this follow-up form is such that each form should fit on a timeline with distinct start and stop dates that do not overlap any other forms.

!Completing the Baseline Form
If the associated Post-CTED (4100) form has not yet been completed for the same time point, the edit form icon will appear disabled (see Figure 1 below). When the user hovers over the icon, it will display that the 4100 is not yet completed. The user must complete the Post-CTED (4100) form in order to enable the edit icon and allow for completion of the form. Data reported on Post-CTED (4100) form are used to validate questions on Cellular Therapy Essential Data Follow-Up (4100) form.

Figure 1. Disabled Edit Form Icon

*Reporting Data for Each Reporting Period
The data reported on the Post-Cellular Therapy Follow up (4101) Form should match the reporting period on the corresponding Post-CTED (4100) Form.

*Subsequent Infusions
If the recipient received a subsequent infusion, the answers to all questions should reflect the clinical status of the recipient the day prior to the start of the lymphodepleting (LD) therapy or, if no LD therapy was given, the answers to all questions should reflect the clinical status of the recipient the day prior to infusion.

Combined follow up
In scenarios where both HCT and cellular therapy forms are being completed, there are two scenarios where the Post-CTED (4100) and Post-Cellular Therapy Follow-Up (4101) forms are 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 and date of contact should match between the corresponding Post-HSCT Data (2100) or Post-Transplant Essential Data (2450) form.

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 and date of contact should match between the corresponding Post-HSCT Data (2100) or Post-Transplant Essential Data (2450) form.

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 Combined Follow Up section of the Data Management Guide.

Links to sections of form:
Q1-3: Survival
Q4-8: Disease Relapse or Progression
Q9-19: Current Hematologic Findings
Q20-45: Persistence of Cells

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

To reference the historical Manual Change History for this form, review the retired manual section on the Retired Forms Manual webpage.

Date of Change	Manual Section	Add/Remove/Modify	Description
1/23/2026	4101: Post-Cellular Therapy Follow-Up	Add	Version 2 of the Cellular Therapy Essential Data Pre- Infusion section of the Forms Instructions Manual released. Version 2 corresponds to revision 2 of the Form 4101.

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