NCT03226704Enrolling by invitation

Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Background: Leukapheresis is a procedure to separate and collect white blood cells. It is the first step in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be offered to people when their cancer comes back. The collected T-cells are used to make a special version of T-cells called CARs. Researchers want to collect these cells from people who may become eligible for a CAR T-cell study in the future. Objective: To identify people who have a high likelihood to benefit from CAR T-cell therapy early in their disease course and collect and store a T-cell product. Eligibility: People ages 3-65 with a form of leukemia or lymphoma that has not been cured by standard therapy Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Review of existing MRI, x-ray, pathology specimens/reports or CT images may be done. On this study, participants will have leukapheresis. A needle will be placed into the arm. Blood will be collected and go through a machine. White blood cells will be taken out by the machine. The plasma and red cells will be returned to the participant through a second needle in the other arm. The procedure will take 4-6 hours. Some participants may have a central line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the needles in the arms-especially if they are smaller. For a central line placement, a long thin tube is inserted through a small incision into the main blood vessel leading into the heart that would allow access to the blood to do the leukapheresis procedure. Participants cells will be processed and frozen for future use in a CAR T-cell therapy study.

Status (registry): Enrolling by invitation
Study type: Observational
Enrollment: 120 (estimated)
First submitted: 21 Jul 2017
Start date: 14 Aug 2017
Primary completion date: 31 Jan 2030
Lead sponsor: National Cancer Institute (NCI)
Diseases: Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma, Childhood cancers
NCT number: NCT03226704

What you commit to

Study type: Observational
Planned participants: 120
From 14 Aug 2017 to the primary completion date, 31 Jan 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met. Cytopenias deemed to be disease-related and not therapyrelated are exempt from this exclusion.

Other illness

Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
Rapidly progressive disease or hyperleukocytosis \>= 50,000 blasts/mcL
Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate CAR or adoptive cell therapy-based toxicity
Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at screening
Human Immunodeficiency Virus (HIV) infection at screening (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities)

Lab values

Transfusion refractory thrombocytopenia such that platelet count cannot be adequately supported with transfusions to be at \>=30,000/mcL
Pregnant or nursing (lactating) individuals, where pregnancy is defined as the state of after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening

Other

Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures

Criteria the registry did not label

INCLUSION CRITERIA:
Age: \>= 3 and \<= 65 years
Weight \>= 15 kg
Confirmation of cancer diagnosis provided by disease-specific assessment (e.g., flow cytometry, PCR) or H\&E verification.
Disease Status:
- Relapsed/refractory cancer that has failed at least one standard regimen and are not in remission at the time of leukapheresis, OR
- Previously treated patients without detectable disease at the time of leukapheresis but at high-relapse risk.
Potentially eligible for future NIH-CAR or other adoptive cell therapy based on the following:
- Adequate performance status: Patients \> 10 years of age: Karnofsky \>= 50%; Patients \<= 10 years of age: Lansky scale \>= 50%
- Adequate organ function:
- absolute neutrophil count \>750/mcL\*
- platelets \>=30,000/mcL\*
- total bilirubin \<=2 X ULN (except in the case of subjects with documented Gilbert s disease \> 3x ULN)
- AST(SGOT)/ALT(SGPT)\<=20 X institutional upper limit of normal for age and laboratory normal ranges
- creatinine within age adjusted normal institutional limits (see below) OR
- creatinine clearance \>= 60 mL/min/1.73 m\^2 for creatinine levels above institutional normal.
Age (Years): \<=5; Maximum Serum Creatine (mg/dL): 0.8
Age (Years): 5 \< age \<= 10; Maximum Serum Creatine (mg/dL): 1.0
Age (Years): \>10; Maximum Serum Creatine (mg/dL): 1.2
- Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.
- Patients, parents/guardians, legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the Informed Consent Document.

Age in the registry: 3 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.