Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase|
- The Rate of Major Cytogenetic Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
- The Rate of Complete Cytogenetic Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The Rate of Complete and Major Cytogenetic Responses at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The Rate of Minor Cytogenetic Responses at 6 and 12 Months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- The Rate of Complete Hematologic Responses at 6 and 12 Months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2001|
|Study Completion Date:||July 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Cytarabine/ Imatinib Mesylate||
Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycleDrug: imatinib mesylate
Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
- Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine.
- Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen.
- Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022490
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Study Chair:||Brian J. Druker, MD||OHSU Knight Cancer Institute|