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, click here.

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.

!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

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).

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).

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. Illustrations of the combined follow up scenarios can also be found the Guide.

Links to sections of form:
Q1: Product:
Q2-4: Survival:
Q5-22: Disease Relapse or Progression:
Q23-33: Current Hematologic Findings:
Q35-59: 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.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
1/23/2024	4101: Post-Cellular Therapy Follow-Up	Add	Added the text in red: CAR-T cells that target antigens (e.g., CD19) on B-cells do not distinguish between cancerous and normal B-cells. As result, the recipient can develop B-cell aplasia (low number or absence of B-cells). B-cell aplasia can be used as a surrogate to track persistence of the product. If the recipient has B-cell aplasia, then the product may still be present. Examples include (but not limited to) “cellular immunology report”, “lymphocyte subsets”, or “B-cell panel” of applicable tests that will show B-cell populations.
1/15/24	4101: Post-Cellular Therapy Follow-Up	Modify	Added the text in red: Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This occurs when disease relapses and the tumor develops partial or complete loss of the tumor antigen. This may be determined by testing (e.g. T-cell subset profile) on the blood and/or bone marrow showing absence of the tumor antigen targeted by the cellular therapy they received. Common testing methods are listed in question 6. Example 1: A recipient has a CD19 expressing disease prior to the cell therapy infusion, such as acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). The recipient is given a CD19-directed CAR T-cell therapy, achieves a CR then relapses. At the time of relapse, the T-cell subset profile shows the absence of CD19 B Cells. This means the leukemia/lymphoma cells no longer express CD19.
12/12/23	4101: Post-Cellular Therapy Follow-Up	Modify	Reformatted and created an example: Example 1: A recipient has a CD19 expressing disease prior to the cell therapy infusion, such as acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). The recipient is given a CD19-directed CAR T-cell therapy, achieves a CR then relapses. At the time of relapse their leukemia/lymphoma cells no longer express CD19.
8/22/23	4101: Post-Cellular Therapy Follow-Up	Modify	Update: Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This is occurs when disease relapses and the tumor develops partial or complete loss of the tumor antigen. An example is a recipient with acute lymphoblastic leukemia (ALL) that expresses the CD19 antigen prior to cellular therapy infusion.
8/22/23	4101: Post-Cellular Therapy Follow-Up	Add	New blue note box added under question 5: Antigen escape occurs in the context of relapse.
7/28/2023	4101: Post-Cellular Therapy Follow-Up	Add	Version 1 of the 4101: Post- Cellular Therapy Follow-Up section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the form 4101.

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