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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STI571

Group Type EXPERIMENTAL

imatinib mesylate

Intervention Type DRUG

Interventions

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imatinib mesylate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No