A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Composite complete rate
研究概览
简要总结
The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
- •Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
- •Age ≥18 years old, gender not limited.
- •ECOG score of 0-
- •Adequate organ function.
排除标准
- •Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
- •A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients.
- •Major surgery and vaccine treatment within 4 weeks.
- •Uncontrolled concurrent diseases.
- •Pregnant or breastfeeding female subjects.
研究组 & 干预措施
IBI188+azacitidine
1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
干预措施: IBI188 (Drug)
IBI188+azacitidine
1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
干预措施: Azacitidine (Drug)
IBI188+decitabine
R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
干预措施: IBI188 (Drug)
IBI188+decitabine
R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
干预措施: Decitabine (Drug)
结局指标
主要结局
Composite complete rate
时间窗: 24 weeks
Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery
次要结局
- Cytogenetic CR(24 weeks)