National Cancer Institute (NCI)
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.
Background: * Leukapheresis is a necessary step to developing a "CAR therapy" or other adoptive cellular therapy products. There are numerous clinical trials underway in the NCI utilizing CAR therapy. * The purpose of this protocol is to develop a streamlined process whereby patients undergo apheresis for development of a CAR cell or other adoptive cell therapy product on a subsequent therapeutic clinical trial, which can be administered when the patient needs investigational therapies. * Emerging data suggests the critical importance of elements of the apheresis product in outcomes following…
* 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: Patie…
Leukapheresis