Use and Tolerability of Imatinib Mesylate (Gleevec®) in Patients With Philadelphia-Positive Chronic Myeloid or Acute Leukemia During the First 100 Days Following Bone Marrow or Stem Cell Transplantation
Imatinib mesylate is an FDA-approved, commercially available drug for patients with acute or
chronic leukemias carrying the Philadelphia chromosome. Women who are able to have children
must have a negative blood pregnancy test before taking this drug
No earlier than three weeks after the bone marrow or stem cell transplant, you will start
taking imatinib mesylate by mouth. You will take it once or twice a day until roughly 100
days following the transplant or until you are released from the Houston area by your M. D.
Anderson physician. Imatinib mesylate should be taken with a meal and a glass of water,
preferably in the morning.
The dose will be gradually increased as long as you don't experience severe side effects. If
severe side effects occur, imatinib will be stopped, either temporarily or permanently.
After about 100 days (or after leaving Houston) the medication may be continued at the
discretion of the study doctor, but the study will be considered completed.
This is an investigational study. A total of up to 40 patients will take part in this
study. All will be enrolled at M. D. Anderson. The study is partially funded by the
manufacturer of imatinib mesylate (see below), although the drug is not provided free of
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
100 Days and 1 Year
Paolo Anderlini, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|