JPRN-jRCTs041180099已完成2 期
Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study) - JALSG APL212G
Takeshita Akihiro0 个研究点目标入组 56 人开始时间: 2019年3月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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