Azacitidine in Combination With or Without All-trans Retinoic Acid in Newly Diagnosed Unfit Acute Myeloid Leukemia or Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS
详细描述
Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition)
- •Be at least 18 years of age on day of signing informed consent
- •Not suitable for newly diagnosed patients with intensive chemotherapy
- •Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation
- •The proportion of blast cells was below 50% in bone marrow
- •Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets
排除标准
- •Malignant neoplasms with other progression
- •Serious mental illness uncooperative
- •Refusal to join the study
研究组 & 干预措施
Azacytidine Combined With ARTA
Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days
干预措施: Azacitidine (Drug)
Azacytidine Combined With ARTA
Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days
干预措施: all trans retinoic acid (Drug)
Azacytidine
Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle
干预措施: Azacitidine (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 24months
time from randomization to death from any cause, or last known date to be alive.
Progression-free survival (PFS)
时间窗: 24 months
Progression-free survival (PFS) will be measured from time of enrolling in the clinical trial to the date on which disease progresses or the date on which the patient dies, whichever comes first.
Overall Response Rate （ORR)
时间窗: 6 months
Number of participants (responders) achieving ORR after the 6 cycle treatments，Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI).
次要结局
- Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline(6 months)
- Incidence of systemic infections(6 months)