Treatment protocol for AP
Phase 2
- Conditions
- Acute promyelocytic leukemia
- Registration Number
- JPRN-jRCTs071180040
- Lead Sponsor
- Takase Ken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Acute promyelocytic leukemia by WHO classification
2. The first time treatment example which does not catch chemotherapy or the radiotherapy
3. The case that is equal to or less than 80 years old more than age 15 years old
4. Performance status 0-2
5. A case without the dangerously ill internal organs disorder
6. The case that an agreement by the document is provided from a patient on explanation because of final examination contents
Exclusion Criteria
1. The case having double cancers
2. The case with an infectious disease having difficulty with control
3. The case with a severe mental disorder
4. The pregnancy or breast-feeding woman
5. The case that the medical attendant judged to be inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3 years disease-free survival
- Secondary Outcome Measures
Name Time Method 5 years disease free survival <br>CR rate <br>Perfection rate of protocol regimen <br>treatment-related toxicities <br>Incidence rate of differentiation syndrome <br>Frequency of additional administration of idarubicune <br>Frequency of mutation in PML-RARA fusion gene and its influence for therapy efficacy