Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study)
Phase 3
- Conditions
- Previously untreated Chronic-phase chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000000823
- Lead Sponsor
- Japan Adult Leukemia Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Not provided
Exclusion Criteria
1. Other active neoplasma 2. Severe infection 3. Anticancer drug other than hydoroxurea in 2 weeks 4. Severe psychological disorders such as shizophrenia 5. Pregnant and/or lactating woman 6. Uncontorlled diabetis meritis 7. Acute myocardial infarction in 1 year or history of heart failure 8. Liver chirosis 9. Otherwise eligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular response at 12 months of imatinib therapy
- Secondary Outcome Measures
Name Time Method 1 Overall survival at three years 2 Cytogenetic response at 2 years 3 Adverse events grade 3 and more