NCT00030394

Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

A Phase II Study of Gleevec in Ph+ Chronic Phase Chronic Myelogenous Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2002-09-01
• Primary completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States