NCT06363994招募中3 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
InnoCare Pharma Inc.38 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2024年5月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
- 试验地点
- 38
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
- •Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
- •Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
- •At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm).
- •ECOG PS score of 0 to 2.
排除标准
- •Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- •Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
- •Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
- •Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
- •Known central nervous system lymphoma.
研究组 & 干预措施
Arm A
Active Comparator
干预措施: Orelabrutinib (Drug)
Arm A
Active Comparator
干预措施: Rituximab (Drug)
Arm B
Active Comparator
干预措施: Orelabrutinib Placebo (Drug)
Arm B
Active Comparator
干预措施: Rituximab (Drug)
Arm B
Active Comparator
干预措施: Bendamustine Injection (Drug)
Arm A
Active Comparator
干预措施: Bendamustine Injection (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
时间窗: Approximately 7 years
次要结局
未报告次要终点
研究者
研究点 (38)
Loading locations...
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