4000: Cellular Therapy Essential Data Pre-Infusion

This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. CAR-T cells, tumor-infiltrating lymphocytes, and cytotoxic T cells are common cellular therapies that should be reported using this form. Regenerative medicine indications can be reported using this form with the exception of genetic modified hematopoietic stem cells to treat malignant hematologic or other non-malignant indications. These infusions are considered transplants and should be reported using the Pre-Transplant Essential Data (Pre-TED) Form 2400.

For recipients of hematopoietic cellular transplants (HCT), complete the Pre-TED (2400) and Disease Classification (2402) forms.

Donor Lymphocyte Infusions (DLI) are no longer captured on the Pre-CTED (4000) form.
An infusion can be classified as a DLI when:

• It’s an infusion of a lymphocyte-only product
• The infusion must be post-Allogeneic HCT and will most likely be from the same HCT donor
• The product cannot be genetically modified
  

Donor Lymphocyte Infusion (2199) form should be completed.

This form reflects pre-infusion essential data for a course of cellular therapy. All cellular therapies (non-HCT) are collected on this form, including indications that reflect donor cellular infusions (DCI) done post-transplant, now referred to as “post-HCT cellular therapy”. A course of cellular therapy includes all infusions given per protocol, or when multiple infusions are given for the same indication using the same product/donor (e.g., post-HCT cellular therapy (DCI)).

*Multiple infusions of commercially available products require a separate Pre-Cellular Therapy Essential Data (4000) forms for each infusion.

The use of cellular therapy is expanding. Treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g. cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR T-cells).

!Consent Status and Baseline Forms
There has been a change to the functionality of submitting the Pre-Transplant Essential Data (2400), Pre-Transplant Essential Data Disease Classification (2402), and Pre-Cellular Therapy Essential Data (4000) forms. If a consent status has not yet been reported for a recipient, the edit form icon will appear disabled (see Figure 1 below). When the user hovers over the icon, it will display that consent has not yet been reported for that recipient (see Figure 2 below). The user should go to the Consent Tool (see Navigation to the Consent Tool) and document the recipient’s consent status in order to enable the edit icon and allow for completion of the form.

Figure 1. Disabled Edit Form Icon

Figure 2. Hovered Text, Consent Not Yet Reported

Links to sections of form:
Q1-17: Recipient Data
Q18-32: Cellular Therapy and HCT History
Q33-57: Product Identification
Q58-77: Indication for Cellular Therapy
Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy
Q89-99: Hematologic Findings Prior to Lymphodepleting Therapy
Q100-102: Functional Status
Q103-113: Comorbid Conditions

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
3/13/2024	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated instructions in Q9 to clarify RCI-BMT is now known as CIBMTR CRO Services: If the study sponsor is reported as BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, PedAL, or Investigator initiated, specify the ClinicalTrials.gov identification number. The letters “NCT” do not need to be included in the field. I
3/13/2024	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated hyperlink in Q8 for CIBMTR CRO Services: https://cibmtr.org/CIBMTR/Studies/Research-Programs/Clinical-Trials-Support/CRO-Services
3/13/2024	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated instructions in Q8 to clarify RCI-BMT is now known as CIBMTR CRO Services: For the infusion being reported on this form, indicate if the recipient is a registered participant with BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, a Corporate / Industry trial, EudraCT, UMIN, an investigator-initiated trial and/or another clinical trial sponsor, regardless if that sponsor uses CIBMTR forms to capture outcomes data.
1/12/24	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the red warning box regarding clinical trials from question 9: Products that are commercially available are no longer under a clinical trial. However, if a commercial product is being used within the context of a clinical trial for a new indication or the product is “out of specification”, report the clinical trial in this question.
1/12/24	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the red warning box regarding clinical trials from question 8: Products that are commercially available are no longer under a clinical trial. However, if a commercial product is being used within the context of a clinical trial for a new indication or the product is “out of specification”, report the clinical trial in this question.
8/28/2023	Q81-91: Comorbid Conditions	Remove	Condensed instructions for reporting comorbidities in Q92 and Q93
8/22/2023	4000: Cellular Therapy Essential Data Pre-Infusion	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	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Version 10 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 10 corresponds to revision 10 of the Form 4000.

Copyright © 2004-2024 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.