A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
Phase 3
- Conditions
- A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
- Registration Number
- JPRN-UMIN000007909
- 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
- 450
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of the treatment with the tyrosine kinase inhibitor except for imatinib within two weeks 2. Registered case in the other clinical trial 3. Detected T315I mutation in the BCR-ABL gene 4. History of allogenic hematopoietic stem cell transplantation 5. Impaired cardiac function 6. Other active neoplasms 7. Active infection requiring the treatment 8. Pregnant and/or lactating woman 9. Severe psychiatric disorders 10. Severe or uncontrolled comorbidities (diabetes, etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative achievement of CMR by 18 months
- Secondary Outcome Measures
Name Time Method Efficacy (Cytogenetic Response, Molecular Response) PFS Safety Continuity