NCT04486391终止3 期
A Multicenter, Open-Label, Randomized Controlled Phase 3 Study of Tislelizumab Monotherapy Versus Salvage Chemotherapy in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
BeiGene14 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年12月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 14
- 主要终点
- Progression-free Survival (PFS) by Investigator
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator
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
- •1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and
- •Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or
- •Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate.
- •2. Must have measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •4. Must have adequate organ functions.
- •Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of study drug, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1
排除标准
- •Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma.
- •Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug.
- •Prior therapies targeting PD-1 or PD-L
- •Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
- •Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
- •Serious acute or chronic infection requiring systemic therapy.
- •Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tislelizumab
Experimental
Tislelizumab monotherapy for up to 45 months
干预措施: Tislelizumab (Drug)
Salvage chemotherapy
Experimental
Salvage chemotherapy for up to 45 months
干预措施: Salvage Chemotherapy (Drug)
结局指标
主要结局
Progression-free Survival (PFS) by Investigator
时间窗: Up to 45 months
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first
次要结局
- Number of participants experiencing Serious Adverse Events (SAEs)(Up to 45 months)
- Time to Response (TTR) by Investigator(Up to 45 months)
- Overall survival (OS)(Up to 45 months)
- Number of participants experiencing Adverse Events (AEs)(Up to 45 months)
- Duration of Response (DOR) by Investigator(Up to 45 months)
- Overall Response Rate (ORR) by Investigator(Up to 45 months)
- Rate of Complete Response (CR) by Investigator(Up to 45 months)
研究者
研究点 (14)
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