Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study)
- Conditions
- acute promyelocytic leukemia (APL)
- Registration Number
- JPRN-C000000206
- Lead Sponsor
- Japan Adult Leukemia Study Group
- Brief Summary
1) Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission (CR). 2) A total of 175 patients negative for PML-RARalpha at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86). 3) Predicted 6-year DFS was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the two groups (P = 0.20). 4) Predicted 6-year survival of patients assigned to the observation was 98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = 0.014).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 234
Not provided
1. Uncontrolled active infection 2. Past history of myocardial infarction or cardiac failure 3. Past history of renal failure 4. Uncontrolled diabetes mellitus 5. Liver cirrhosis 6. Leukemic involvement in the CNS 7. Another severe and/or life threatening disease 8. Pregnant and/or lactating woman 9. Positive for HIV antibody test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relapse-free survival at 5 years
- Secondary Outcome Measures
Name Time Method overall survival at 5 years, complete remission rate, event-free survival at 5 years, efficacy of detection of PML-RARalpha