Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients
1. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation.
- To identify any clinically significant drug interactions with imatinib in the post-transplant setting.
- To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting.
- To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Toxicity Rate [ Time Frame: 100 Days and 1 Year ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2003|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
|Experimental: Imatinib Mesylate||
Drug: Imatinib Mesylate
Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
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 charge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386373
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Paolo Anderlini, MD||M.D. Anderson Cancer Center|