This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. Recipients of CAR T cells, donor lymphocyte infusions, tumor-infiltrating lymphocytes, cytotoxic T cells are common cellular therapies that should be reported using this form. Regenerative therapy indications can only be reported using this form with the exception of genetic modified hematopoietic stem cells to treat hematologic or other non-malignant indications 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.

This form reflects baseline recipient data and indication for a course of cellular therapy. All cellular therapies (non-HCT) are being collected on this form, including indications that reflect donor cellular infusions (DCI/DLI) 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/DLI)). 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
3/17/2021 4000: Cellular Therapy Essential Data Pre-Infusion Modify Clarification added to the blue note box about reporting co-morbidities within 6 months of the cellular therapy: Please report co-morbidities that occurred were detected within six months of the cellular therapy, which is different than HCT reporting. The 6 month rule applies to assessments that need to be performed in order to determine if a comorbidity is present (i.e., PFT for pulmonary, liver values for hepatic, creatinine for renal, BMI for obesity, etc.). If the co-morbidity is denoted as “ANY history”, the 6 month rule does not apply.
1/25/2021 4000: Cellular Therapy Essential Data Pre-Infusion Modify Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/22/2021 4000:Cellular Therapy Essential Data Pre-Infusion Modify Version 5 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 5 corresponds to revision 7 of the form 4000.
Last modified: Mar 17, 2021

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