Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing (NCT03226704) | Clinical Trial Compass
By InvitationNot Applicable
Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing
United States120 participantsStarted 2017-08-14
Plain-language summary
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.
Who can participate
Age range
3 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is 'enrolling by invitation only,' can you help me understand how patients get selected for it, and whether it might be relevant to my specific situation?
2My understanding is that this trial is about collecting and banking my immune cells through a process called apheresis — so the goal isn't treatment itself, but preparing me for a possible future CAR-T therapy. Can you walk me through what that means for my current treatment timeline?
3The main thing this trial is measuring is whether patients who bank their cells can successfully enroll in a CAR-T study within about 12 months — so if I were to participate, what happens if I'm not eligible for a CAR-T study within that window?
4Since this is a cell-collection study rather than a treatment study, what are the real-world risks or side effects of the apheresis procedure itself that I should be aware of before agreeing to participate?
5If I bank my cells now through this kind of study, does that limit or change my options for pursuing standard treatments like chemotherapy in the meantime, or can both paths run in parallel?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
fraction of subjects who can enroll on a CAR-T study within approximately 12 months of undergoing apheresis
Timeframe: 12 months after collection of apheresis product