Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Higher-Dose Gleevec (STI571)
Imatinib mesylate is a new oral medication that blocks a protein that is responsible for CML
Before treatment starts, patients will have a physical exam, blood tests, and a bone marrow
study. The bone marrow will be removed with a large needle. Women able to have children
will have a screening blood or urine test for pregnancy.
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. Bottles containing the tablets will be given
to the patient every 6 months. Unused supplies must be returned at the end of the study.
After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated.
If the response is good, treatment with imatinib mesylate alone will be continued.
Treatment may be continued for up to 20 years, or as long as it is judged best to control
the leukemia.
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. Imatinib mesylate has been approved in CML. A total of
125 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Molecular Response
After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated.
3 - 12 months
No
Jorge E Cortes, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
ID01-151
NCT00038649
August 2001
November 2014
Name | Location |
---|---|
M.D. Anderson Cancer Center | Houston, Texas 77030 |