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A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
Sponsor: Hutchmed
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-03-20
Completion Date
2028-12-30
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
HMPL-760
Patients will receive HMPL-760 once daily (QD) orally.
HMPL-760 Placebo
Patients will receive HMPL-760 placebo once daily (QD) orally.
R-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