RecruitingPhase 3NCT07409428

A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

A Phase III Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination With R-GemOx Versus Placebo in Combination With R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor

Hutchmed

Enrollment

240 participants

Start Date

Mar 20, 2026

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Summary

This is a Phase III randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with R/R DLBCL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HMPL-760, a drug called HMPL-760 Placebo, and others for people with relapsed/refractory diffuse large b-cell lymphoma. The study is currently recruiting participants at 41 locations. People eligible for this study include aged 18 Years and older.

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

DRUGHMPL-760

Patients will receive HMPL-760 once daily (QD) orally.

DRUGHMPL-760 Placebo

Patients will receive HMPL-760 placebo once daily (QD) orally.

DRUGR-GemOx

R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg/m2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg/m2 IV followed by oxaliplatin 100 mg/m2 IV is given on Day 2 of each cycle.

Locations(41)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Baoding NO.1 Central Hospital

Baoding, China

Beijing GoBroad Hospital

Beijing, China

BEIJING TONGREN HOSPITAL, Capital Medical University

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

People's Hospital of Hunan Province

Changsha, China

The Second Xiangya Hospital of Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Quanzhou First Hospital.Fujian

Fujian, China

Fujian Medical University Union Hospital

Fuzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

ZhuJiang Hospital of Southern Medical University（The Second Clinical Medical College）

Guangzhou, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Qilu Hospital of Shandong University

Jinan, China

Shandong Cancer Hospital & Institute

Jinan, China

Jiangxi Cancer Hospital

Nanchang, China

Jiangsu Cancer Hospital

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Tongji Hospital of Tongji University

Shanghai, China

Shengjing Hospital of China Medical University

Shenyang, China

Shanxi Provincial Cancer Hospitial

Taiyuan, China

North China University of Science and Technology Affiliated Hospital

Tangshan, China

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

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Tianjin People's Hospital

Tianjin, China

Cancer Hospital Affiliated to Xinjiang Medical University

Ürümqi, China

Hubei Cancer Hospital

Wuhan, China

Wuhan Union Hospital of China

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT07409428

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