Post remission therapy including arsenic trioxide against acute promylocytic leukemia (APL) in elderly patients. (JALSG APL212G study)

Phase 2

• Conditions: Adult acute promylocytic leukemia

• Registration Number: JPRN-jRCTs041180099
• Lead Sponsor: Takeshita Akihiro

Brief Summary

Brief summaryWe conducted a prospective study in newly diagnosed elder APL with a median follow-up of 5.8 (0-8.8) years. Of 56 eligible patients who had received ATRA and chemotherapy, 49 (88%) achieved complete remission. Within 30 days after starting induction, 7 cases died. After completion of 2 courses of consolidation with arsenic trioxide, 47 patients (84%) achieved molecular remission, and underwent maintenance with tamibarotene. 3 cases relapsed. EFS was 71%. OS and RFS was 73% and 83%, respectivel

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-14
• Study Completion: 2022-03-01
• Results First Posted: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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