Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00171899

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia	Drug: imatinib mesylate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STI571	Drug: imatinib mesylate

Arm

Intervention/Treatment

Experimental: STI571

Drug: imatinib mesylate

Outcome Measures

Primary Outcome Measures

Percent of patients achieving major molecular response at baseline and at last visit []

Secondary Outcome Measures

Complete cytogenetic response at baseline and at last visit []
Overall survival []
Disease progression-free survival []
Quality of Life assessment at baseline, last visit []
Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic myelogenous leukemia with Philadelphia chromosome
18 years and older
Patients must have been taking imatinib mesylate standard dose for at least 12 months and have achieved a complete cytogenetic response but not a major molecular response.

Exclusion Criteria:

Patients with cardiac problems such as congestive heart failure, or myocardial infarction within the last 6 months
Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic renal (kidney) disease or active uncontrolled infection.
Patients with other current primary malignancy or malignancy requiring active intervention

Other protocol defined inclusion/exclusion criteria may apply.