Chronic Phase Chronic Myelogenous Leukemia Clinical Trial
Official title:
A Phase II Study of Gleevec in Ph+ Chronic Phase Chronic Myelogenous Leukemia
This phase II trial is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
OBJECTIVES:
I. Determine the response rate in patients with Philadelphia chromosome positive chronic
phase chronic myelogenous leukemia treated with imatinib mesylate.
II. Determine the disease-free survival of patients treated with this drug. III. Determine
the pharmacokinetics of this drug in these patients. IV. Determine the toxic effects of this
drug in these patients. V. Determine the rates of hematological, cytogenetic, and molecular
response and time to response in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (chronic
myelogenous leukemia [CML] in first chronic phase after failing interferon therapy or
demonstrating intolerance to interferon [closed to accrual as of 12/05/03] vs CML relapsing
after stem cell transplantation or in second or subsequent chronic phase [closed to accrual
as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior treatment [closed
to accrual as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior
treatment).
Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28
days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who
fail to achieve a complete hematologic response after 3 courses or a partial or complete
cytogenic response after 6 courses are removed from the study.
PROJECTED ACCRUAL: A total of 109 patients (30 for stratum I [closed to accrual as of
12/05/03] and stratum II [closed to accrual as of 7/29/05], 34 for stratum III [closed to
accrual as of 7/29/05], and 45 for stratum IV) will be accrued for this study within 2
years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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