NCT07377578招募中3 期
A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)
Guangzhou Lupeng Pharmaceutical Company LTD.2 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2026年2月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 394
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS) assessed by IRC
研究概览
简要总结
Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).
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
- Single (Investigator)
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
- •Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy.
- •Have at least one measurable lesion according to the Lugano Response Criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-
- •Life expectancy ≥ 12 weeks.
- •Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function, etc.
- •Toxicities or complications from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.
- •All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating.
- •Subject voluntarily enrolls and signs the informed consent form, and agrees to comply with the study treatment plan and visit schedule.
排除标准
- •Hypersensitivity to Rocbrutinib or any study drug in the control group.
- •Prior treatment with any BTK-targeted therapy (except for intolerance).
- •Central nervous system (CNS) involvement by lymphoma.
- •History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, localized squamous cell carcinoma, etc.
- •History of major cardiovascular events within 6 months prior to randomization.
- •Presence of any severe and/or uncontrolled systemic disease that, in the investigator's judgment, or have poor cardiac function.
- •Uncontrolled active bacterial, fungal, or viral systemic infection, or active tuberculosis infection.
- •Any medical condition that could interfere with the absorption, distribution, metabolism, or excretion (ADME) of the investigational drug or the evaluation of study outcomes.
研究组 & 干预措施
Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)
Active Comparator
干预措施: Ibrutinib (Drug)
Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)
Active Comparator
干预措施: Acalabrutinib (Drug)
Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)
Active Comparator
干预措施: Zanubrutinib (Drug)
Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)
Active Comparator
干预措施: Orelabrutinib (Drug)
Arm A (Rocbrutinib)
Experimental
干预措施: Rocbrutinib (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by IRC
时间窗: approximately 30 months
次要结局
- PFS assessed by INV(approximately 30 months)
- Overall Response Rate (ORR) assessed by IRC and INV, respectively(Up to approximately 24 months)
- Duration of Response (DOR) assessed by IRC and INV, respectively(approximately 30 months)
- Overall Survival(approximately 40 months)
- Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0(Up to approximately 40 months)
- Number of participants with treatment-related adverse event as assessed by CTCAE v5.0(Up to approximately 40 months)
研究者
研究点 (2)
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