Protocol
12-146
Full Title
Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy with Bortezomib Combined with Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma
Purpose
Very few patients with leukemia or lymphoma associated with the human T-cell leukemia virus type 1 (HTLV-1) are cured of their disease using traditional chemotherapy. The goal of this study is to evaluate the safety and effectiveness of a new combination of three therapies to treat patients with HTLV-1-associated leukemia or lymphoma:
- EPOCH chemotherapy, a combination of the drugs etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin
- Raltegravir, an antiviral drug called an integrase inhibitor which blocks HTLV-1 and which is approved for treating HIV
- Bortezomib, a chemotherapy drug which stops the growth of T-cell leukemia and lymphoma cells by blocking the breakdown of certain proteins. Bortezomib is already approved for treating mantle cell lymphoma and myeloma
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CD3-positive HTLV-1-associated leukemia or lymphoma.
- This study is open to patients who have had no prior therapy as well as those who had previous treatment.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Ariela Noy at 212-639-7423.
Disease(s)
Leukemia
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
ClinicalTrials.gov
