Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825)
Dasatinib is an anticancer drug that is designed to block the function of BCR-ABL, which is
the abnormal protein responsible for causing leukemia in certain cells.
If you are found to be eligible to take part in this study and you agree, you will take
dasatinib once every day while on study. Dasatinib should be taken by mouth with water.
Every 1-2 weeks during the first 4 weeks of the study, you will have around 2 tablespoons of
blood drawn for routine blood tests. The blood tests will be repeated every 4-6 weeks until
1 year from when you started therapy and then every 3-4 months until 2 years, then every
4-6 months for as long as you are on the study. A bone marrow aspiration will also be taken
every 3-4 months for the first year and then every 6-12 months until 3 years then every 2-3
years for as long as you are on the study to check on the status of the disease.
You will be given a medication diary to monitor any missed doses. You will also be asked to
visit the doctor for a physical exam and to have vital signs measured periodically. These
visits will be scheduled at least every 3-4 months for the first year, then every 6 to 12
months while you are on the study. The visits may be scheduled more often depending on the
status of the disease.
Treatment may be continued for up to 8-10 years or as long as the doctor feels it is
necessary to control the leukemia. If the disease gets worse or you experience any
intolerable side effects, you will be taken off the study and your doctor will discuss other
treatment options with you. If you decide to stop participating in the study, you are
encouraged to discuss your decision with your study doctor.
For Patients Already Enrolled:
If you have already been enrolled on this study and were assigned to receive dasatinib twice
a day, you will be able to continue to receive the study drug on that schedule. However, if
you experience side effects, the study doctor may choose to switch you to the once daily
schedule if he feels that it may help to get rid of or decrease the risk of side effects.
This is an investigational study. Dasatinib is investigational and is approved by the FDA
for clinical trials only. A total of 150 patients will take part in this study. All will be
enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to first Molecular Response prior to 12 months (MMR)
MMR measured every 3 months
Jorge Cortes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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