Therapy of Late Chronic Phase Chronic Myelogenous Leukemia (CML) With High-Dose Gleevec (STI571)
Treatment: Imatinib mesylate is a new oral medication that blocks a protein that is
responsible for CML
Patients on this study will take 400 mg of imatinib twice daily (morning and evening). If
you have side effects, the dose may be lowered. If you are taking less than 800 mg of
imatinib, you can take your dose once per day or divided in two doses. Imatinib mesylate
should be taken with a large glass of water.
After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated.
Treatment may be continued for up to 20 years, or as long as it is judged best to control
Update June 2010:
Blood tests are recommended 2 times per year. Your doctor will discuss with you how often
you should have blood tests. Bone marrow will be done if your doctor thinks it is necessary
to check your disease. You must return to M. D. Anderson at least once every year. You may
not need a bone marrow test every visit, but you will have blood drawn to measure the amount
of disease you have. If the leukemia cannot be found for 2 years or longer on the blood
test called PCR which is done to measure the amount of disease you have, your doctor may
talk to you about stopping treatment with imatinib. If you and your doctor decide to stop
your therapy, you will have a blood test for PCR done every 3 to 6 months. You do not need
to return to M. D. Anderson to have this blood test done. You may have the blood taken by
your local doctor and mailed to M. D. Anderson. If the leukemia is found again by the PCR
blood test, your doctor may recommend that you restart treatment with imatinib. You may
decide to stay on treatment with imatinib even if your PCR blood test does not show any sign
of leukemia for 2 years or longer.
This is an investigational study. The FDA has authorized the use of imatinib mesylate for
patients with CML. It is the dose of imatinib mesylate being used that is investigational. A
total of 50 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
Cytogenetic CR Rate
At 6 months
Jorge E Cortes, MD
The University Of MD Anderson Cancer Center
United States: Institutional Review Board
|The University Of MD Anderson Cancer Center||Houston, Texas 77030|