Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia
2020年4月16日 更新者:Junmin Li、Shanghai Jiao Tong University School of Medicine
Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia : An Open-Label, Single-Arm, Phase 2 Study.
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
29
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Kai Xue
- 电话号码:+86-13818659448
- 邮箱:xuekaishanghai@126.com
研究联系人备份
- 姓名:Hongming Zhu
- 邮箱:daphnezhming@163.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age: 60-75
- Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
- ECOG:0-2
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
A humanized monoclonal immunoglobulin
其他名称:
A DNA methyltransferase inhibitor
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall response rate
大体时间:6 months
|
CR, CRi, and morphologic leukemia-free state (MLFS)
|
6 months
|
|
Complete remission (CR) rate
大体时间:6 months
|
Blast and promyelocytic leukemia less than 5% in bone marrow
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progress-free survival (PFS)
大体时间:2 years
|
PFS is defined from the date of entry on study until disease progression, including treatment failure, relapse from CR, or death from any causes.
|
2 years
|
|
Overall survival (OS)
大体时间:2 years
|
OS is defined for patients entering the study as time to death of all causes.
|
2 years
|
|
6-month overall survival rate
大体时间:6 months
|
To evaluate overall survival rate at 6 months from study entry.
|
6 months
|
|
12-month overall survival rate
大体时间:12 months
|
To evaluate overall survival rate at 12 months from study entry.
|
12 months
|
|
Hematological and non-hematological toxicity
大体时间:2 years
|
Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03.
|
2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Junmin Li、Ruijin Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年4月25日
初级完成 (预期的)
2020年12月31日
研究完成 (预期的)
2022年12月31日
研究注册日期
首次提交
2020年4月14日
首先提交符合 QC 标准的
2020年4月16日
首次发布 (实际的)
2020年4月20日
研究记录更新
最后更新发布 (实际的)
2020年4月20日
上次提交的符合 QC 标准的更新
2020年4月16日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.