CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies

Acute Lymphoblastic Leukemia Clinical Trial

Official title: CD19+ Chimeric Antigen Receptor T Cells for Patients With Advanced Lymphoid Malignancies

Status Completed

Clinical Trial Summary

This phase I clinical trial studies the side effects and best dose of CD19-specific T-cells in treating patients with lymphoid malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment. Sometimes researchers change the deoxyribonucleic acid (DNA) (genetic material in cells) of donated T-cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. Injecting modified T-cells made from the patient may help attack cancer cells in patients with advanced B-cell lymphoma or leukemia.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the safety and maximum tolerated dose of genetically modified, CD19-specific T cells administered into patients with CD19+ advanced lymphoid malignancies.

SECONDARY OBJECTIVES:

I. To screen for the development of host immune responses against the CD19-specific chimeric antigen receptor (CAR).

II. To describe the homing ability of the infused T cells. III. To assess disease response. IV. To determine persistence of CAR+ T cells.

OUTLINE: This is a dose escalation study of CD19 positive chimeric antigen receptor T-cells.

LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate intravenously (IV) over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician.

Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1.

After completion of study treatment, patients are followed up for at least 15 years. ;

Related Conditions & MeSH terms

• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia
• Blasts 5 Percent or More of Bone Marrow Nucleated Cells
• CD19 Positive
• Leukemia
• Leukemia, Biphenotypic, Acute
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Minimal Residual Disease
• Neoplasm, Residual
• Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Small Lymphocytic Lymphoma
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

• NCT number: NCT02529813
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2015
• Completion date: November 8, 2021