At a glance
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An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide, and 2 other interventions for Primary Mediastinal B-cell Lymphoma and 3 related conditions. Completed, enrolled 43 participants across 1 site.
Detailed Summary
Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with B cell lymphomas or leukemias that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-cluster of differentiation 19 (CD19) incorporated in the retrovirus. Objective: The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink. Eligibility: \- Adults age 18-70 with B cell lymphomas or leukemias expressing the CD19 molecule. Design: Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-CD19 cells. Leukapheresis is a common procedure, which removes only the white blood cells from the patient. Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
Study Details
Timeline
Interventions
Days -5 to -1 (after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Days -5 to -4: 60mg/kg intravenous (IV) over 60 minutes
Anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) peripheral blood lymphocytes ( PBL). Day 0 (two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Day 0: 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
Days -5 to -3 (after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Days -5 to -3: 300mg/m\^2 intravenous (IV) over 60 minutes