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.
Induction therapy consists of ATRA and chemotherapy whose dose and duration were based on initial white blood cell (WBC) count. Patients who achieve hematological remission are treated with 4 courses of consolidation therapy:
arsenic trioxide for the first and the third course; daunorubicin and cytosine arabinoside for the second course; and gemtuzumab ozogamicin for the forth course. Patients who achieve molecular remission after consolidation therapy are received maintenance therapy with tamibarotene.
Consolidation and maintenance are composed of single arm.
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. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome.
10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.