A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
- •Participants had either:
- •Relapsed cHL, defined as disease progression after a partial response (PR) or complete response (CR) to their most recent therapy; or
- •Refractory cHL, defined as failure to achieve PR or CR to their most recent therapy.
- •Participants were assigned to one of two cohorts based on the following:
- •Cohort 1: Participants who were relapsed or refractory after prior autologous hematopoietic stem cell transplantation (HSCT):
- •Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).
- •Were not considered candidates for additional autologous or allogeneic HSCT (a transplant using donor stem cells).
- •Cohort 2: Participants who were relapsed or refractory to salvage chemotherapy and had not received prior HSCT:
- •Were not considered candidates for autologous or allogeneic HSCT.
- •Had received at least one prior systemic therapy regimen for cHL.
- •Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.
- •Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, indicating full activity or restricted activity but capable of self-care.
排除标准
- •Participants had nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
- •Participants had received prior allogeneic HSCT.
- •Participants had received prior therapy targeting immune checkpoint pathways, including programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
- •Participants had active autoimmune disease or a history of autoimmune disease with potential to relapse.
- •Note: Additional inclusion and exclusion criteria defined in the protocol may have applied.
研究组 & 干预措施
Cohort 1
Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.
干预措施: Tislelizumab (Drug)
Cohort 2
Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.
次要结局
- Complete Response Rate (CRR)(From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.)
- Duration of Response (DOR)(From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.)
- Time to Response (TTR)(From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.)
- Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks))