2025-524241-27-00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.86 个研究点 分布在 5 个国家目标入组 102 人开始时间: 2026年7月1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
- 102
- 试验地点
- 86
- 主要终点
- Randomization Stage: Progression-free survival (PFS) assessed by Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL)
研究概览
简要总结
Randomization Stage: To compare the effect of orelabrutinib plus BR vs BR on PFS in treatment-naїve subjects with MCL
研究设计
- 分配方式
- Randomized
- 主要目的
- Arm B - Control arm
- 盲法
- Double (Analyst, Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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.
- •Have not received prior systemic therapies for MCL.
- •Modified Ann Arbor stage II-IV. Subjects 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.
- •Uncontrolled or significant cardiovascular diseases
- •History of hemophilia A, hemophilia B, von Willebrand disease or requiring anticoagulation with warfarin or equivalent vitamin K antagonists or have a spontaneous bleeding tendency assessed by the Investigator.
- •History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study treatment.
- •Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects who have undergone total gastrectomy.
- •Have undergone major surgery within 30 days prior to the first dose of study treatment.
研究组 & 干预措施
Orelabrutinib
Test
干预措施: Orelabrutinib (Drug)
Bendamustine Glenmark, 2,5 mg/ml, proszek do sporządzania koncentratu roztworu do infuzji
Comparator
干预措施: Bendamustine Glenmark, 2,5 mg/ml, proszek do sporządzania koncentratu roztworu do infuzji (Drug)
Truxima 100 mg concentrate for solution for infusion
Comparator
干预措施: Truxima 100 mg concentrate for solution for infusion (Drug)
Tablet matching the appearance of orelabrutinib (used only at randomisation stage, not at safety and tolerability stage)
Placebo
干预措施: Tablet matching the appearance of orelabrutinib (used only at randomisation stage, not at safety and tolerability stage) (Drug)
结局指标
主要结局
Randomization Stage: Progression-free survival (PFS) assessed by Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL)
Randomization Stage: Progression-free survival (PFS) assessed by Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL)
次要结局
- Randomization Stage: Overall Survival (OS)
- Randomization Stage: Efficacy Endpoints o PFS assessed by Investigator according to iwNHL o ORR, CRR. DOR and TTR assessed by IRC and Investigator according to iwNHL Time to next treatment (TTNT)
- Randomization Stage: Safety Endpoints AEs assessed by CTCAE v5.0 criteria, VS, PE, ECG, ECOG performance status and laboratory findings
- Randomization Stage: o PK Endpoint o Plasma concentrations of orelabrutinib
- Randomization Stage: Assessment of Patient-Reported Outcomes o Quality of life assessment: Time to worsening, health score and changes from baseline in FACT-Lym and EQ-5D-5L
研究者
Xin Chen
Scientific
Innocare Pharma Inc.
研究点 (86)
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