Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
- Registration Number
- NCT00171899
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STI571 imatinib mesylate -
- Primary Outcome Measures
Name Time Method Percent of patients achieving major molecular response at baseline and at last visit
- Secondary Outcome Measures
Name Time Method Complete cytogenetic response at baseline and at last visit Disease progression-free survival Overall survival Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications Quality of Life assessment at baseline, last visit
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇦Toronto, Canada