Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00030394
Brief Summary:
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
Detailed Description:
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.
Study:
NCT00030394
Study Brief:
Protocol Section:
NCT00030394