NCT07784101尚未招募3 期
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 24
- 主要终点
- Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).
研究概览
简要总结
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).
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
- •Known intolerance to orelabrutinib or pirtobrutinib treatment.
- •Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
- •Patients with other malignancies within 2 years prior to enrollment.
- •Uncontrolled or significant cardiovascular disease.
- •Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
- •Participants with severe central nervous system diseases.
- •Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
- •Underwent major surgery within 4 weeks prior to the first dose.
- •Active infections require systemic treatment.
- •Active autoimmune diseases.
- •Known central nervous system lymphoma.
- •Known alcohol or drug dependence.
排除标准
- •Known intolerance to orelabrutinib or pirtobrutinib treatment.
- •Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
- •Patients with other malignancies within 2 years prior to enrollment.
- •Uncontrolled or significant cardiovascular disease.
- •Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
- •Participants with severe central nervous system diseases.
- •Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
- •Underwent major surgery within 4 weeks prior to the first dose.
- •Active infections require systemic treatment.
- •Active autoimmune diseases.
- •Known central nervous system lymphoma.
- •Known alcohol or drug dependence.
结局指标
主要结局
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).
时间窗: 6 years
次要结局
- Investigator-assessed PFS according to Lugano 2014.(6 years)
- IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014(6 years)
- IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014(6 years)
- IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014(6 years)
- IRC-assessed and investigators-assessed time to first response (TTR) according to Lugano 2014(6 years)
- Time to next treatment (TTNT)(6 years)
- Overall Survival (OS)(6 years)
- Eastern Cooperative Oncology Group (ECOG) performance status(6 years)
研究者
研究点 (24)
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