NCT04342936Unknown3 期
A Randomized,Open-label Phase III Study of Camrelizumab (SHR-1210) vs. Investigator's Choice of Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is an open-label, multicenter, randomized, phase3 trial to evaluate the efficacy of Camrelizumab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Camrelizumab monotherapy or chemotherapy of investigators' choice.
The primary hypotheses of this study are that treatment with Camrelizumab prolongs Progression-free Survival (PFS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with Chemotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With histologically confirmed classic Hodgkin's lymphoma ;
- •Relapsed or refractory cHL meet either of the following criteria:
- •Did not achieve remission or progressed after autologous hematopoietic stem cell transplantation.
- •Received at least 2 lines of systemic chemotherapy, failed to achieve remission or progressed after the most recent chemotherapy.
- •Have measurable disease according to Lugano 2014 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance scale of 0 or 1;
- •Life expectancy ≥ 12 weeks;
- •Has adequate organ function;
- •Women of childbearing potential（WOCBP） must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
- •Able to understand and sign an informed consent form (ICF).
排除标准
- •Active, known or suspected autoimmune disease. Subjects who were in a stable state, do not need systemic immunosuppressive therapy were allowed to participate.
- •Concurrent medical condition requiring the use of immunosuppressive medications or glucocorticoids exceeds a daily dose of 10mg prednisone or equivalent within 14 days before drug administration. Topical use of glucocorticoids is allowed.
- •Received anti-tumor vaccines or other anti-tumor therapy with immune stimulatory effects within 3 months before the first dose SHR-
- •Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- •Participating in other clinical studies or less than 4 weeks by the end of the most recent clinical trial participation;
- •Known or suspected interstitial pneumonia;
- •Concurrent or history of other malignancies. (Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who received radical treatment and did not relapse in 5 years since treatment initiation).
- •Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤
- •Prior allo-HSCT.
- •ASCT within 90 days.
- •Impact of major surgery or severe trauma had been eliminated for less than 14 days.
- •Active pulmonary tuberculosis.
- •Severe acute or chronic infection requiring systemic therapy.
- •Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
- •Live vaccine within 4 weeks before the first dose SHR-1210.Inactivated vaccines against seasonal influenza is allowed.Live attenuated influenza vaccines were not approved for intranasal administration.
- •HIV test(s) positive or known AIDS.
- •Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
- •Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection .
研究组 & 干预措施
Camrelizumab for Injection
Experimental
Participants receive Camrelizumab 200mg intravenously (IV) on Day 1 of each 2-week cycle
干预措施: Camrelizumab (Drug)
Chemotherapy
Active Comparator
Participants receive investigator's choice of chemotherapy (Gemox, IGEV or DHAP) for up to 6 cycles.
干预措施: Investigator's choice of Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: anticipated 16 months
Time from randomisation to radiologically confirmed progressive disease
次要结局
未报告次要终点
研究者
研究点 (1)
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