This form must be completed for all recipients of cellular therapy (non-HCT) where it is the first indication for treatment (no prior hematopoietic cell transplant), when a post-HCT cellular therapy event (e.g. DCI, CAR-T) is reported on an HCT follow up form, or when cellular therapy (non-HCT) is reported as a new indication following a marrow toxic injury (RITN patient) / non-cellular therapy (e.g. chemotherapy, immunotherapy).
For recipients of hematopoietic cellular transplants, complete the pre-TED Form 2400 and Disease Classification F2402.
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 Form 4000 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).
Q1-14: Recipient Data
Q15-29: Cellular Therapy and HCT History
Q30-54: Product Identification
Q55-69: Indication for Cellular Therapy
Q77-102: Disease Assessment at Last Evaluation Prior to Cellular Therapy
Q103-107: Systemic Therapy Prior to Cellular Therapy
Q108-110: Functional Status
Q111-120: Comorbid Conditions
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.
|11/13/2020||4000:Cellular Therapy Essential Data Pre-Infusion||Modify||Clarified the time period for reporting co-morbid conditions prior to a cellular therapy infusion: Added the following guidance on answering question 37: Additionally, for the purposes of this manual, the term “at the time of patient assessment” is defined as the pre-infusion evaluation period performed with 6 months prior to the start of the lympho-depleting or preparative regimen.|
|10/23/2020||4000:Cellular Therapy Essential Data Pre-Infusion||Add|| Added the following guidance on answering question 37:
Question 37 has been “hidden” in FormsNet3 for the current revision of this form. If an NMDP donor ID had been previously entered, this field will not be hidden and can be edited as needed. However, if an NMDP donor ID has not been entered yet, this field will be hidden and skipped until the form is revised and the question is removed from the form.
|9/23/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify||Corrected the formatting in the list of co-morbid conditions under question 115.|
|9/18/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify||Updated the instruction for reporting the new FDA approved product “Tecartus”: Please report the new FDA approved product ‘Tecartus (brexucabtagene autoleucel)’ as ‘Yescarta’. The products will be distinguished by the lymphoma histology. The new product name will be added to the option list in the next revision to be released in January 2021.|
|9/9/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Add||Clarification added on how to report ADD and ADHD as comorbidities to question 115: Psychiatric disturbance – The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks.|
|8/26/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Add||Blue instruction box added above question 111 to clarify how to report the COVD-19 infections when diagnosed after the start of the lymphodepleting therapy: Diagnosis of COVD-19 after the start of the lymphodepleting therapy: Questions 111 – 113 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the lymphodepleting therapy / infusion. If a COVID-19 infection is diagnosed after the start of the lymphodepleting therapy, report the COVID-19 diagnosis on the post-infusion follow-up form (2450, 2100, and / or 4100).|
|8/3/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify||Updated the instruction for reporting NCT ID: “All clinical trials are required to be registered on the clinicaltrials.gov website and will have an associated identification number. Report the number in question 12, do not include the letters “NCT” that precede the digits.”|
|7/29/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Add||Added the following note box under question 49: Please report the new FDA approved product ‘Tecartus (brexucabtagene autoleucel)’ under “other product” and specify the name as ‘Tecartus’ in question 50 until the name can be added to the option list.|
|6/9/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Add||Provided clarification (red text) on how to report heart valve comorbidity for question 115. Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by the most recent heart evaluation by an echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse. This does not include a documented medical history of heart valve disease.|
|6/8/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify||Add clarification: For the infusion being reported on this form, indicate if the recipient is a registered participant with BMT-CTN, 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.|
|5/21/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify|| Q106- Clarified the instructions for reporting drug dose: Report the total
|5/20/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify|| Q104- Clarified the instructions for reporting drug dose: For each drug listed, checking the box will indicate it was given as part of the lymphodepleting therapy used prior to the cellular therapy infusion. Report the total
|5/11/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Add||Included instructions for questions that were added to the form (questions 111-113) intended to capture information on COVID-19 (SARS-CoV-2) infections.|
|4/7/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Add||For question 109-100, added the following guidance for Karnofsky/Lansky scores: Documentation from an RN who has been trained and authorized to determine performance scores may also be used.|
|1/24/2020||4000: Cellular Therapy Essential Data Pre-Infusion||Modify||Version 4 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 4 corresponds to revision 6 of the form 4000.|
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