Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Phase 3
Completed
- Conditions
- Chronic Myelogenous Leukemia in Chronic Phase
- Registration Number
- NCT00237120
- Lead Sponsor
- Novartis
- Brief Summary
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
- Previously untreated with Interferon-alpha
- Performance status is normal or capable of only limited self-care
Exclusion Criteria
- Patients who are pregnant or possibly pregnant
- Significant hepatic diseases
- Chronic Myelogenous Leukemia in advanced phase
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 3 years overall survival Duration of remaining in chronic phase
- Secondary Outcome Measures
Name Time Method Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib, Adverse event