Chronic Myelogenous Leukemia Clinical Trial
Official title:
Phase II "Proof of Concept" Study of TALL-104 (MHC Non-Restricted Cytotoxic T-Cell Line) and Imatinib Mesylate (Gleevec) in Chronic Myelogenous Leukemia in Chronic Phase
Objectives:
- To determine the response rate and duration of response with combination of TALL-104
cells and imatinib mesylate (IM) therapy in patients with chronic myelogenous leukemia
in chronic phase, that have not achieved, or have lost, adequate response to IM.
- To determine the toxicity of the combination of TALL-104 cells and IM therapy in this
patient population.
Imatinib mesylate is designed to block the enzyme that is believed to be responsible for
starting the type of leukemia patient has. TALL-104 cells are cells of the immune system
that have been obtained from a patient with leukemia and then processed in the laboratory to
try to make them able to kill leukemia cells.
If found to be eligible to take part in this study, patient will continue receiving imatinib
mesylate by mouth at the same schedule and dose patient had been receiving before entering
the study. Patient will receive TALL-104 cells through a needle in their vein over 1 hour on
Days 1-4, and then again on Days 7, 10, 14, 17, and 21 of the cycle. The cycle will last 28
days.
Blood (about 1 tablespoon) will be drawn every week for the first 4 weeks, then every 2-4
weeks for 2 months, then every 4-6 weeks until 6 months, and then every 3-6 months for
routine tests and to check for any effect on organs.
Patient will have follow-up visits at 1 month, 3 months, 6 months, and at least annually for
2 years, and then at least every 5 years from then on for the rest of your life. Blood
(about 1 teaspoon) will be drawn to check the status of the disease. An additional 1
tablespoon will also be collected and stored to be analyzed in case unexpected side effects
occur after receiving therapy. If patient experiences certain side effects, more blood may
need to be drawn and more tests performed based on the side effects experienced.
Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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