Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia (JALSG APL212)
- Conditions
- Adult acute promylocytic leukemia
- Registration Number
- JPRN-jRCTs041180100
- Lead Sponsor
- Takeshita Akihiro
- Brief Summary
We conducted a prospective study in newly diagnosed adult APL with a median follow-up of 6.5(0-9.3)years. Of 218 eligible patients who had received ATRA and chemotherapy, 202 (93%) achieved complete remission. Within 30 days after starting induction, 8 cases died. After 4 courses of consolidation with ATO and chemotherapy, 186 patients (85%) achieved molecular remission, and underwent maintenance with tamibarotene. Eleven cases relapsed. EFS was 88%. OS and RFS was 91% and 94%, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 218
1. Newly diagnosed APL (FAB: M3 or M3v)
2. Performance status (ECOG): 0-2
3. Adequate cardiac, pulmonary, hepatic and renal function
4. Written informed consent
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
- Secondary Outcome Measures
Name Time Method