Protocol
11-048
Full Title
A Phase I Trial of Consolidation Therapy with Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients with Chronic Lymphocytic Leukemia Following Upfront Chemotherapy with Pentostatin, Cyclophosphamide and Rituximab
Purpose
This study is evaluating a new gene therapy for patients with chronic lymphocytic leukemia (CLL) that persists despite standard chemotherapy. The therapy uses white blood cells called T cells that have been modified to recognize and kill leukemia cells by targeting a protein on CLL cells called CD19.
The modification is achieved by taking T cells from a patient’s blood and inserting a gene into them. The goal of this study is to find the optimal dose of these modified T cells that can be given to patients with CLL that persists despite initial chemotherapy.
T cells that were modified in this way were shown to cure a cancer similar to CLL in mice. Early studies in patients who received the therapy showed tumor shrinkage or a slowing of tumor growth in some patients.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CLL that persists despite prior treatment with pentostatin, cyclophosphamide, and rituximab.
- Patients may not have previously been treated by allogeneic or stem cell transplantation.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.
Disease(s)
Leukemia
Leukemia: Chronic Lymphocytic Leukemia
Locations
ClinicalTrials.gov
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