NCT04514081招募中2 期
A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- ORR assess by investigators per the 2014 Lugano classification
研究概览
简要总结
This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. 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 1 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 illness.
研究组 & 干预措施
Chidamide+Decitabine+Camrelizumab
Experimental
干预措施: Chidamide; Decitabine; Camrelizumab (Drug)
Decitabine+Camrelizumab
Active Comparator
干预措施: Decitabine+Camrelizumab (Drug)
结局指标
主要结局
ORR assess by investigators per the 2014 Lugano classification
时间窗: 3 years
rate of subjects achieved objective response in all evaluable subjects
Number of Subjects with treatment-related adverse events (AEs)
时间窗: 3 years
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
次要结局
未报告次要终点
研究者
Han weidong
Professor
Chinese PLA General Hospital
研究点 (1)
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