Prospective, Open-label, Single Arm Trial to Evaluate Efficacy and Safety of Tislelizumab with Azacitidine in the Treatment of Refractory/relapsed Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- composite complete remission rate
研究概览
简要总结
Acute myeloid leukemia(AML) is a clonal hematological malignancy. 50%-90% adult AML patients can achieve complete remission(CR) after standard induction chemotherapy,but 10%-25% patients cannot achieve CR, which is called 'primary refractory disease'.Most of patients who achieved CR will relapse during the next 3 years, and the prognosis is poor.So refractory and relapse diseases are still the hotspot of clinical research.Immunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy. Studies have shown that PD1 and PDL1 levels are upregulated in AML patients, the same phenomenon was observed after the treatment of demethylating agents such as azacytidine. Combination of PD1 blockades with azacytidine may improve the efficacy of the treatment.
详细描述
In this phase 1/2 study, 20 patients will be enrolled and treated with azacytidine and tislelizumab regimen. The primary endpoint is composite complete remission rate.Toxicities of treatment need to be observed. And relationship between PDL1 expression on AML cells and efficacy will be studied. Treatments include azacytidine 75mg/m2/d, subcutaneous injection,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •diagnosis of AML according to FAB or WHO criteria
- •refractory or morphological relapsed AML
- •age over 18 years old
- •ECOG PS 0-2
- •written informed consent
排除标准
- •acute promyelocyte leukemia
- •solitary extramedullary relapsed disease
- •other hematological diseases
- •antecedent stem cell transplantation
- •AML with BCR_ABL positive
- •acute panmyelosis with myelofibrosis or sarcoma
- •with other active organ malignancy(needing treatment)
- •active heart diseases
- •unfit for enrollment after investigator's evaluation
研究组 & 干预措施
treatment arm
azacytidine 75mg/m2/d, IH,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses
干预措施: Aza, tislelizumab (Drug)
结局指标
主要结局
composite complete remission rate
时间窗: up to 2 years
including complete remission plus complete remission with incomplete blood cell count recovery
次要结局
- overall survival(up to 4 years)
- disease free survival(up to 4 years)