RecruitingPhase 3NCT06363994

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

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

Sponsor

InnoCare Pharma Inc.

Enrollment

476 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Mantle Cell Lymphoma

Summary

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new drug combination — orelabrutinib (a BTK inhibitor that blocks cancer cell signaling) plus standard chemotherapy (bendamustine and rituximab) — versus chemotherapy alone for elderly patients with newly diagnosed mantle cell lymphoma, a type of blood cancer. **You may be eligible if...** - You are 65 or older (or 60–64 and ineligible for or have declined stem cell transplant) - You have newly diagnosed mantle cell lymphoma confirmed by biopsy - You have not received any prior treatment for this cancer - You have at least one measurable tumor - You are in acceptable overall health (ECOG 0–2) **You may NOT be eligible if...** - You have already received systemic treatment for mantle cell lymphoma - You have other serious medical conditions affecting your ability to tolerate treatment - Your cancer does not meet the required stage or lab criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.

DRUGBendamustine Injection

Eligible patients will receive Bendamustine by injection as per the protocol

DRUGRituximab

Eligible patients will receive Rituximab by injection as per the protocol

DRUGOrelabrutinib Placebo

Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Locations(39)

Beijing Cancer Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

The First People's Hospital of Changzhou

Changzhou, China

Sichuan Provincial People's Hospital

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Chongqinq Cancer Hospital

Chongqing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The second Hospital of Dalian Medical University

Dalian, China

Fujing Cancer Hospital

Fuzhou, China

Union Hospital Affiliated to Fujian Medical University

Fuzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Zhejiang University Medical School affiliated to the first Hospital

Hangzhou, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Cancer Hospital of Shandong First Medical University

Jinan, China

Shandong Provincial Hospital

Jinan, China

The First Affiliated Hospital of Ningbo University

Jinan, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Nanjing, China

Cancer Hospital Affiliated to Fudan University

Shanghai, China

Huashan Hospital of Fudan University

Shanghai, China

Shengjing Hospital of China Medical University

Shenyang, China

The First Affiliated Hospital of China Medical University

Shenyang, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Shanxi Cancer Hospital

Taiyuan, China

Tianjin Cancer Hospital

Tianjin, China

The Tumor Hospital Affiliated to Xinjiang Medical University

Ürümqi, China

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and

Wuhan, China

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and

Wuhan, China

The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)

Xi'an, China

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, China

Yibin Second People's Hospital

Yibin, China

Henan Cancer Hospital

Zhengzhou, China

Henan Provincial People's Hospital

Zhengzhou, China

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