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 baseline recipient data and indication 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).

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
Q85-88: Toxicity Prophylaxis
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
10/17/2022 Q113-127: Comorbid Conditions Modify Removed the following text: Indicate whether the total serum ferritin result was Known or Unknown prior to the start of lymphodepleting therapy. If Known, report the result and the unit of measure in question 102, and report the date (MM-DD-YYYY) of the test in question 103.
9/29/2022 Q113-127: Comorbid Conditions Add Added blue note box above question 122: Prior to answering Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI) question, review the list of co-existing disease(s) and/or organ impairments listed below.
9/29/2022 Q113-127: Comorbid Conditions Modify Updated text in red: Current Diagnosis at the Time of Pre- Infusion Evaluation
9/29/2022 Q113-127: Comorbid Conditions Modify Moved ‘Rheumatologic’ and ‘Prior malignancy, requiring treatment’ to the Documented medical history list. Added ‘heart value disease’ under Current Diagnosis at the Time of Pre-Infusion Evaluation
9/29/2022 Q113-127: Comorbid Conditions Modify Removed text from the blue note box: Hepatic and Renal Comorbidities Report all comorbidities including those that are considered complications of the primary disease for infusion. See examples below.
9/23/2022 4000: Cellular Therapy Essential Data Pre-Infusion Modify Version 9 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 9 corresponds to revision 9 of the Form 4000.
Last modified: Oct 17, 2022

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