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)
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Sign the ICF and be able to follow the requirements of study protocol;
• Age ≥18 years;
• ECOG performance status score between 0 and 2;
• Histopathologically confirmed diagnosis of DLBCL;
• The investigator judges that the patient's current condition requires further treatment;
• Patients should have at least one bi-dimensionally measurable lesion;
• Expected survival is more than 12 weeks;
Locations
Other Locations
China
Baoding NO.1 Central Hospital
RECRUITING
Baoding
Beijing GoBroad Hospital
RECRUITING
Beijing
BEIJING TONGREN HOSPITAL, Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
People's Hospital of Hunan Province
RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Quanzhou First Hospital.Fujian
RECRUITING
Fujian
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
ZhuJiang Hospital of Southern Medical University（The Second Clinical Medical College）
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The First Affiliated Hospital, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital & Institute
RECRUITING
Jinan
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Jiangsu Cancer Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shenzhen people's hospital
NOT_YET_RECRUITING
Shenzhen
Shanxi Provincial Cancer Hospital
RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Tianjin People's Hospital
RECRUITING
Tianjin
People's Hospital of Xinjiang Uygur Autonomous Region
NOT_YET_RECRUITING
Ürümqi
The First Affiliated Hospital of WMU
NOT_YET_RECRUITING
Wenzhou
Hubei Cancer Hospital
RECRUITING
Wuhan
Wuhan Union Hospital of China
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal)
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Dongmei Chen, CPL
dongmeic@hutch-med.com
86-21-20671794
Time Frame
Start Date: 2026-03-20
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 240
Treatments
Experimental: The experimental group
Patients will receive HMPL-760 once daily (QD) orally in combination with 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.
Placebo_comparator: The control group
Placebo QD at the same dose as HMPL-760 in the experimental group will be given in the control group, and the combination therapy is the same as in the experimental group.
Related Therapeutic Areas
Sponsors
Leads: Hutchmed