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, neurotoxicity), 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 the center’s cell therapy reporting preference and in 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, click here.

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).

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
Q2-3: Survival
Q4-11: Subsequent Cellular Infusions
Q2-14: Best Response to Cellular Therapy
Q15-23: Peripheral Blood Count Recovery
Q24-25: Disease Relapse or Progression
Q26: New Malignancy, Lymphoproliferative or Myeloproliferative Disease/Disorder
Q27-46: Graft vs. Host Disease
Q47-177: Toxicities
Q178-189: Infection
Q190-191: 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.

Date	Manual Section	Add/Remove/Modify	Description
7/26/2024	4100: Cellular Therapy Essential Data Follow-Up	Add	Instructions added to Q4
7/26/2024	4100: Cellular Therapy Essential Data Follow-Up	Add	Subsequent HCT and Cellular Therapy red warning box added above Q5
6/11/2024	4100: Cellular Therapy Essential Data Follow-Up	Modify	Normal limits of IgG concentration in the blood vary with age. For adults, levels lower than 600 mg/dL of circulating IgG are considered to be hypogammaglobulinemia. Children ages 4 to 10 18, levels lower than 500 mg/dL are considered hypogammaglobulinemia.
5/22/2024	4100: Cellular Therapy Essential Data Follow-Up	Add	Added new note regarding combined follow up for question 148: In scenarios where an HCT was given after a cellular therapy and this form is now being completed based on the subsequent HCT date, these questions do not apply and are disabled.
4/26/2024	4100: Cellular Therapy Essential Data Follow-Up	Modify	Correction of required to received: Questions 138-139: Did the recipient require receive immunoglobulin replacement therapy? Replacement therapy is given to prevent infections. If the recipient required received immunoglobulin replacement therapy (IVIG) regardless of hypogammaglobulinemia that developed post-infusion, select Yes and indicate if the recipient is still requiring receiving the therapy on the contact date for this reporting period. If the last immunoglobulin replacement therapy (IVIG) was given less than 6 months from the date of contact, report Yes unless it’s clearly stated in the medical record that no more immunoglobulin replacement therapy is required.
4/23/2024	4100: Cellular Therapy Essential Data Follow-Up	Modify	Updated blue box above question 24: The disease relapse or progression questions are applicate applicable for malignant diseases that do not generate when a disease specific form s (e.g., AML, CML, MDS, MPN) are not present or and for the following products are reported in question 1: Letetresgene autoleucel, Other product, or No product name.
1/19/2024	4100: Cellular Therapy Essential Data Follow-Up	Add	Added text in red to the first blue box above question 12: If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL), Non-Hodgkin Lymphoma (NHL), or Multiple Myeloma (MM) and there is a corresponding disease form, best response is not reported on this form.
1/16/2024	4100: Cellular Therapy Essential Data Follow-Up	Add	Added the following text to question 85: Lower scores are associated with a higher level of encephalopathy. Report the lowest score of any evaluation from the reporting period. Unable to complete assessment should be selected when an assessment was started and couldn’t be finish for any reason or the recipient couldn’t perform the evaluation. This should be used rarely since evaluations may be given multiple times a day.
1/15/2024	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added the text in red: Disease relapse or progression can be documented by a variety of methods including molecular, flow cytometry, cytogenetic/fluorescent in situ hybridization (FISH), radiographic or hematological/clinical. The intent is to captures any new relapse or progression event that occurred in the reporting period, not just the initial relapse or progression. Report Yes if any new disease relapse or progression was detected by any one of the methods in the current reporting period and report the first date (YYYY-MM-DD) of the relapse or progression detected.
12/19/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Time frame for reporting the 1Y contact date updated in the Contact Date table in Q2: _F4100 , 1 Year, + 60 days (Day 36 5 6 – 425)
12/12/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Select Not applicable when: The recipient never got immunoglobulin replacement therapy due to never having a decreased IgG level Or There was no decline in IgG levels in this reporting period Or IgG levels were never tested in this reporting period
11/21/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	DO report an infection in the following scenarios: A recipient has a positive COVID-19 diagnostic result (PCR or antigen) or if treatment was given or if the recipient was asymptomatic. regardless of if treatment was given or if the recipient was asymptomatic.
9/7/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Select Not applicable when: The recipient never got immunoglobulin replacement therapy due to never having a decreased IgG level Or There was no decline in IgG levels in this reporting period
8/25/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Diagnosis of COVID-19 after the start of the lymphodepleting therapy: Any COVID-19 infections diagnosed after the start of the lymphodepleting therapy should be reported in the following questions on the Cellular Therapy Essential Data Follow-Up (4100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated. Effective August 25, 2023, the Respiratory Virus Post-Infusion Data (2149) form for infusions on the cellular therapy track will no longer be required. Additionally, an unscheduled Respiratory Virus Post-Infusion Data (2149) form cannot be created for these recipients.
8/24/2023	4100: Cellular Therapy Essential Data Follow-Up	Add	If the recipient never got immunoglobulin replacement therapy and their immunoglobulin levels were never decreased, select Not applicable.
8/22/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Clarified the intention of the question: Indicate if the recipient received pre-exposure drugs for COVID-19 in this reporting period.
7/28/2023	4100: Cellular Therapy Essential Data Follow-Up	Add	Version 9 of the 4100: Post- Cellular Therapy Follow-Up section of the Forms Instruction Manual released. Version 9 corresponds to revision 9 of the form 4100.

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