4100: Cellular Therapy Essential Data Follow-Up

This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT DCI infusions. 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 Essential Data (Post-CTED) follow-up form focuses on key follow-up information for each reporting period, including the survival status of the recipient, additional cellular infusions performed, best response to the cellular therapy, development of new malignancies, development and severity of toxicities (e.g. cytokine release syndrome, IEC-HS, ICANS), infection and fertility information. 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.

The Post-CTED Form schedule is determined by consent status and the infusion details. Each cell therapy infusion will randomize separately. This form will be paired with the Post- Cellular Therapy Follow-Up (4101) form if the infusion is selected for the CRF reporting level. For more information, see the Data Management Guide, Cell Therapy Reporting Levels.

The Post-CTED (4100) Form must be completed at the following time points: 100 days, six months, and annually post-infusion. These forms should be completed as closely to these time points as possible. The structure of the CTED Forms is such that each form should fit on a timeline with distinct start and stop dates that do not overlap any other forms, except in the case of a subsequent infusion.

*Reporting Data for Each Reporting Period
If the Post-CTED (4100) is completed for the Day 100 reporting period, answers to all questions should reflect Day +1 until the reported Day 100 contact date. For the six-month or annual evaluations, the answers to all questions should reflect since the contact date for the prior reporting period until the reported contact date for the current reporting period.

*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.

Subsequent cell therapy

If a recipient receives a cellular therapy between Post-CTED time points (100 day, six months, annually), the form sequence will start over again with another Pre-CTED.

Subsequent HCT

If a recipient receives an HCT after a cell therapy, the forms that are required next depend on whether the cell therapy was genetically modified or not:

1. HCT after a non-genetically modified cell therapy: The form sequence will start over with a new Pre-TED. The cell therapy forms will end.
2. HCT after a genetically modified cell therapy: The form sequence will start over with a new Pre-TED and combined follow up rules apply. See below for more details.
   

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 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).

*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 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.

A full list of enabled/disabled fields can be found on the Combined Follow Up section of the Data Management Guide.

Lost to Follow-Up

Occasionally, centers may lose contact with recipients for a variety of reasons, including the recipient’s moving, changing physicians, or death. If contact with a recipient appears lost, please consider calling the recipient at home or work, sending a letter, communicating with the treating or referring physician, or contacting the hospital billing department. If no documentation exists and several unsuccessful attempts have been made to contact the recipient, they are considered lost to follow-up and the form may be marked as such using the Lost to Follow-Up tool in FormsNet3^SM for each reporting period in which no contact exists.

Links to sections of form:
Q1-2: Survival
Q3: Subsequent Cellular Infusions
Q4-6: Best Response to Cellular Therapy
Q7-18: Peripheral Blood Count Recovery
Q19-20: Disease Relapse or Progression
Q21: New Malignancy, Lymphoproliferative or Myeloproliferative Disease/Disorder
Q22-25: Autoimmune Disorder
Q26-50: Graft vs. Host Disease
Q51-193: Toxicities
Q194-198: Infection
Q199-200: Pregnancy Status

Manual updates:
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.

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

Date	Manual Section	Add/Remove/Modify	Description
2/20/2026	4100: Cellular Therapy Essential Data Follow-Up	Add	Version 10 of the Cellular Therapy Essential Data Pre- Infusion section of the Forms Instructions Manual released. Version 10 corresponds to revision 10 of the Form 4100.

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