An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints
- Registration Number
- NCT01216085
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS
- Patients who provided written informed consent prior to participation to this study
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description imatinib high-dose imatinib Study patients will receive 400 mg twice daily oral administration in the morning and the evening.
- Primary Outcome Measures
Name Time Method Major molecular response 60 months Major molecular response achieved to Month 60 from the time of Glivec treatment
- Secondary Outcome Measures
Name Time Method progression-free survival until 60 months Besides Complete molecular response, complete and major cytogenetic response achieved, event-free survival, and survival without progression to AP/BC achieved to Month 60 from the time of Glivec treatment, Progression-free survival will be evaluated.
number of adverse events until 60 months compliance status and adverse events
Trial Locations
- Locations (1)
Novartis Investigational Site
🇰🇷Seoul, Korea, Republic of