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
Imatinib mesylate is designed to block the enzyme that is believed to be responsible for
starting the type of leukemia you have. 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.
Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in the
study. Your complete medical history will be recorded. You will have a physical exam,
including measurement of your vital signs (blood pressure, heart rate, and temperature).
Blood (about 2 tablespoons) will be drawn for routine tests and 1 additional tablespoon will
be stored to be analyzed in case unexpected side effects occur after you receive your
therapy. You will have a bone marrow aspirate/biopsy to check the status of the leukemia.
To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with
anesthetic and a small amount of bone marrow/bone is withdrawn through a large needle.
Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy
If you are found to be eligible to take part in this study, you will continue receiving
imatinib mesylate by mouth at the same schedule and dose you have been receiving before
entering the study. You will receive TALL-104 cells through a needle in your 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 your organs.
You 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 you receive your therapy. If you experience certain side effects, more blood
may need to be drawn and more tests performed based on the side effects you may experience.
You should inform the study staff if your address or telephone number changes.
This is an investigational study. TALL-104 is not FDA approved or commercially available.
It has been authorized for use in research only. Imatinib mesylate is FDA approved and
commercially available. 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
Response Rate (major and complete cytogenetic response)
Evaluated at 12 months (rate of response by 3 months)
Jorge E. Cortes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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