Blood cell collection could open door to CAR T-Cell therapy for leukemia and lymphoma patients
NCT ID NCT03226704
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 15 times
Summary
This study collects white blood cells from 120 people aged 3 to 65 with leukemia or lymphoma that hasn't been cured by standard treatments. The cells are gathered through a procedure called leukapheresis, then processed and frozen for future use in CAR T-cell therapy. The goal is to identify patients early who could benefit from this advanced treatment and have their cells ready when needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Leukapheresis
- What this could lead to
- If successful, this study could help more people with hard-to-treat blood cancers get CAR T-cell therapy sooner.
- What could go wrong
- This is an early collection study, not a treatment trial. The cells may not be used if the patient's condition changes or if they don't qualify for a future CAR T-cell study.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2017
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients 3-65 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responded to one or more standard regimens and/or deemed incurable by standard therapy and who meet all eligibility criteria are eligible to participate.
- Ages
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3 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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. EXCLUSION CRITERIA: * Transfusion refractory thrombocytopenia such that platelet count cannot be adequately supported with transfusions to be at \>=30,000/mcL * 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 * 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. * 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 * 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) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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