Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- •12 to 75 years of age.
- •ECOG performance of less than
- •Life expectancy of at least 3 months.
- •Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
- •Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- •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 camrelizumab plus decitabine
chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks
干预措施: Chidamide (Drug)
chidamide in combination with camrelizumab plus decitabine
chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks
干预措施: Camrelizumab (Drug)
chidamide in combination with camrelizumab plus decitabine
chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks
干预措施: Decitabine (Drug)
结局指标
主要结局
ORR
时间窗: 3 years
ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Adverse effects
时间窗: 3 years
Adverse effects were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
次要结局
未报告次要终点
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital