Anti-PD-1 Antibody SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma:an Open-label Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- stage II: duration of CR
研究概览
简要总结
This is a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and more effective than treatment with SHR-1210 alone; and reverse the resistance of anti-PD-1 antibody in patients with HL who had previously treated with anti-PD-1 monotherapy. If it is deemed that the combination therapy is more efficacious than SHR-1210 monotherapy (The CR rate of the combination group is at least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in predicting 60 subjects naïve to anti-PD-1 antibody who are randomly assigned (2:1) to the above two groups), the stage II study will be revised to a multicohort, decitabine-plus-SHR1210 single-arm clinical trial. The primary objective of stage II study is to evaluate the long-term response duration with decitabine-plus-SHR-1210 in relapsed or refractory Hodgkin Lymphoma.
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
- •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 four prior chemotherapy regimen, 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.Subjects with Anti-PD-1 antibody are eligible which must be resistance.
- •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 investigational 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
SHR-1210-plus-Decitabine
Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
干预措施: SHR-1210 (Drug)
SHR-1210-plus-Decitabine
Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
干预措施: Decitabine (Drug)
SHR-1210
SHR-1210 200 mg, day 1, every 3 weeks.
干预措施: SHR-1210 (Drug)
结局指标
主要结局
stage II: duration of CR
时间窗: 5 years
Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.
stage I: Number of Subjects with treatment-related adverse events (AEs)
时间窗: 2 years
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
stage I: CRR assess by investigators per the 2014 Lugano classification
时间窗: 3 years
rate of subjects achieved complete response in all evaluable subjects
次要结局
- stage II: duration of response(5 years)
- stage II: Progression free survival(5 years)
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital