Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

Phase 2

Terminated

• Conditions: Leukemia
• Interventions: Drug: cytarabine; Drug: imatinib mesylate

• Registration Number: NCT00022490
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2001-08-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2011-05
• Study Completion: 2011-07
• Results First Submitted: 2012-06-06
• Results First Submitted QC: 2012-06-06
• Results First Posted: 2012-07-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytarabine/ Imatinib Mesylate	cytarabine	-
Cytarabine/ Imatinib Mesylate	imatinib mesylate	-

Primary Outcome Measures

Name	Time	Method
The Rate of Major Cytogenetic Response at 6 Months	6 months	Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.

Secondary Outcome Measures

Name	Time	Method
The Rate of Complete Cytogenetic Response at 6 Months	6 months
The Rate of Complete and Major Cytogenetic Responses at 12 Months	12 months
The Rate of Minor Cytogenetic Responses at 6 and 12 Months	6 and 12 months
The Rate of Complete Hematologic Responses at 6 and 12 Months	6 and 12 months

Trial Locations

Locations (2)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States