Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia : An Open-Label, Single-Arm, Phase 2 Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 29
- 主要终点
- Overall response rate
研究概览
简要总结
This is an open-label, single arm, phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with DNA methyltransferase inhibitor decitabine in elderly patients with relapse and refractory acute myeloid leukemia.
详细描述
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, 29 relapsed or refractory acute myeloid leukemia patients will be enrolled. Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 60-75
- •Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
- •Life expectancy ≥ 3 months
- •Adequate laboratory parameters during the screening period as evidenced by the following:
- •Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
- •ALT and AST ≤ 3 × upper limit of normal (ULN)
- •FEV1,FVC,DLCO ≥ 50% predicted value
- •Left ventricular ejection fraction (LVEF) ≥ 40%, no symptomatic arrhythmia
- •Able to understand and sign an informed consent form (ICF).
排除标准
- •Treatment-related AML
- •Allergic to Camrelizumab, Decitabine, other monoclonal antibody or pharmaceutical excipients
- •Use of immunosuppressive drug within 2 weeks before entering the group
- •Abnormal liver and kidney function(does not meet the inclusion criteria)
- •Suffering from heart failure
- •Active tuberculosis or HIV positive
- •Active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.
- •Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
- •Concurrent medical condition requiring the long-term use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10 mg/day topical prednisone or equivalent
- •Suffer from other hematological neoplasm
- •Known history of use other immune checkpoint inhibitor
- •Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.
研究组 & 干预措施
Camrelizumab(SHR-1210) Combined With Decitabine
Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.
干预措施: Camrelizumab(SHR-1210) (Drug)
Camrelizumab(SHR-1210) Combined With Decitabine
Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.
干预措施: Decitabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: 6 months
CR, CRi, and morphologic leukemia-free state (MLFS)
Complete remission (CR) rate
时间窗: 6 months
Blast and promyelocytic leukemia less than 5% in bone marrow
次要结局
- 12-month overall survival rate(12 months)
- Progress-free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
- 6-month overall survival rate(6 months)
- Hematological and non-hematological toxicity(2 years)
研究者
Junmin Li
Director of Department of Hematology
Shanghai Jiao Tong University School of Medicine