RecruitingPhase 3NCT06082102

Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

324 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Marginal Zone Lymphoma

Summary

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment combinations for people with marginal zone lymphoma (a type of slow-growing blood cancer) that has returned or stopped responding to prior therapy. One group receives orelabrutinib plus rituximab (a BTK inhibitor with a standard cancer antibody) and the other receives lenalidomide plus rituximab. **You may be eligible if...** - You are 18 or older - You have been diagnosed with marginal zone lymphoma (splenic, nodal, or extra-nodal type) - You have already received at least one prior treatment that included a rituximab-type drug - Your lymphoma has relapsed or is no longer responding to treatment - You have at least one measurable lymphoma lesion - Your overall health is good (ECOG 0-2) **You may NOT be eligible if...** - You have received a BTK inhibitor (like ibrutinib or acalabrutinib) before - Your lymphoma has already failed lenalidomide plus rituximab combination therapy - Your lymphoma has spread to the brain or nervous system - You received cancer treatment within the past 2 weeks or an experimental drug within 4 weeks 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOrelabrutinib

Orelabrutinib Tablets

DRUGRituximab

Rituximab Injection

DRUGLenalidomide

Lenalidomide Capsules

DRUGRituximab

Rituximab Injection

Locations(19)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Auhui, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial Peoples Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

The first Hospital of China Medical University

Shenyang, Liaoning, China

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06082102