NCT07082686招募中2 期
A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 29
- 主要终点
- Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
研究概览
简要总结
This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥ 18 years old.
- •Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.
- •The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:
- •Failure of at least one adequate prior line of anti-CD20-containing therapy;
- •Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.
- •Failure of the last line of therapy.
- •At least one measurable lesion according to the Lugano 2014 criteria,.
- •ECOG performance status of 0-2 .
排除标准
- •Current or prior history of central nervous system (CNS) lymphoma.
- •Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.).
- •Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-
- •Prior allogeneic hematopoietic stem cell transplantation.
研究组 & 干预措施
ICP-248Tablets
Experimental
干预措施: ICP-248 (Drug)
结局指标
主要结局
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
时间窗: 3 years
次要结局
- According to Lugano 2014: IRC and investigator assessed complete response rate (CRR)(3 years)
- Investigator-assessed ORR(3 years)
- According to Lugano 2014: IRC and investigator assessed disease control rate (DCR).(3 years)
- According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) .(3 years)
- Overall survival (OS)(3 years)
- According to Lugano 2014: IRC and investigator assessed duration of response (DOR).(3 years)
- According to Lugano 2014: IRC and investigator assessed time to initial response (TTR).(3 years)
- Adverse event (AE) assessed according to CTCAE v5.0 criteria(3 years)
- Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L).(3 years)
- Area under the plasma concentration versus time curve (AUC)(3 years)
- minimal residual disease （MRD） status(3 years)
- Peak Plasma Concentration (Cmax)(3 years)
- Time of maximum observed plasma(Tmax)(3 years)
- Trough concentration(Ctrough)(3 years)
- Apparent clearance (CL/F)(3 years)
研究者
研究点 (29)
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