An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
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
- duration of response
研究概览
简要总结
This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.
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
- •1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- •2 12 to 75 years of age.
- •3 ECOG performance of less than
- •4 Life expectancy of at least 3 months.
- •5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
- •6 Subjects must have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day
- •Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- •7 Subjects must have adequate marrow, live, renal and heart functions.
排除标准
- •1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- •2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- •3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- •4 Prior organ allograft.
- •5 Women who are pregnant or breastfeeding.
- •6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration.
- •7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究组 & 干预措施
Camrelizumab plus decitabine
Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.
干预措施: Camrelizumab and Decitabine (Drug)
结局指标
主要结局
duration of response
时间窗: 5 years
Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
Progression free survival
时间窗: 5 years
Time measured from the day of treatment to the date of first documented progression, or death from any cause
次要结局
未报告次要终点
研究者
Han weidong
Professor
Chinese PLA General Hospital