JPRN-jRCTs041180100已完成2 期
Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study) - JALSG APL212
Takeshita Akihiro0 个研究点目标入组 218 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
- 218
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 64age old（—）
- 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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