Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor : An Open-label Phase I/II Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.
- •18 to 65 years of age.
- •ECOG performance of less than
- •Life expectancy of at least 3 months.
- •Subjects with lymphoma must have at least one measureable new lesion >1.5cm as defined by lymphoma response criteria.
- •Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day
- •Subjects must have adequate marrow, live, renal and heart functions.
排除标准
- •Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- •Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- •Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .
- •Prior organ allograft.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
研究组 & 干预措施
chidamide in combination with decitabine
chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks
干预措施: Chidamide (Drug)
chidamide in combination with decitabine
chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks
干预措施: Decitabine (Drug)
decitabine in combination with Camrelizumab
decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6
干预措施: Decitabine (Drug)
decitabine in combination with Camrelizumab
decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Adverse events
时间窗: 2 years
Adverse events were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0)
CR rate
时间窗: 2 years
CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
次要结局
未报告次要终点
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital