RecruitingPhase 2NCT07189065

A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Enrollment

150 participants

Start Date

Nov 27, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Summary

This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called rocbrutinib for people with a type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or stopped responding to treatment. The study focuses on a specific subtype called non-GCB DLBCL. **You may be eligible if...** - You are 18 or older - You have confirmed non-GCB type DLBCL (a specific subtype identified by lab testing) - Your cancer has relapsed or not responded to at least two prior treatments, including at least one that contained rituximab (an anti-cancer antibody) - You have at least one measurable tumor on imaging - You are not planning to undergo a stem cell transplant - You are well enough to participate (ECOG score 0–2) **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - Your DLBCL developed from a previously diagnosed slow-growing lymphoma - You have another special type of DLBCL (such as EBV-positive or high-grade B-cell lymphoma) - You have active autoimmune disease requiring ongoing immune-suppressing treatment 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

DRUGRocbrutinib

200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.

DRUGBendamustine

Participants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6.

DRUGRituximab

Participants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.

DRUGLenalidomide

20mg qd PO day 1-21

Locations(41)

Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)

Hefei, Anhui, China

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

National Cancer Center/Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Affiliated Hospital of Xiamen University

Xiamen, Hujian, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Jilin, Jilin, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Linyi Cancer Hospital

Linyi, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07189065

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