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More info
You can access this
clinical trial
if you have
Primary Mediastinal B-cell Lymphoma, Diffuse, Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma Transformed From Follicular Lymphoma or Mantle Cell
and you are
between 18 and 70
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Background: The 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-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 18-68 with B cell lymphomas or leukemias expressing the CD19 molecule. Design: Work up stage: Patients will be seen as an outpatient at the 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.

Provided treatments

  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Biological: Anti-CD19-CAR PBL
Tris trial is registered with FDA with number: NCT00924326. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 43 volunteers for the current phase.
Official trial title:
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-cell Lymphoma