Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study)
Phase 2
Recruiting
- Conditions
- Adult acute promylocytic leukemia
- Registration Number
- JPRN-UMIN000008471
- Lead Sponsor
- the Japan Adult Leukemia Study Group (JALSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of myelodysplastic syndrome 2. Atypical acute leukemia 3. Uncontrollable infection 4. Severe co-morbidity 5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody 6. Other active neoplasm 7. Pregnant and/or lactating woman 8. Psychological disorders 9. Patients who have a difficulty to enter the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year event free survival (EFS)
- Secondary Outcome Measures
Name Time Method 1. Complete remission rate (CR) 2. 3- and 5-year disease free survival (DFS)of patients in CR 3. 3- and 5-year overall survival (OS) 4. 5-year event free survival (EFS) 5. CR, DFS and OS of each group 6. Adverse events. 7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis 8. Coagulation and fibrinolysis factors, and their effects on prognosis. 9. Quality of life 10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome. 11. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.