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 (41) 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
NOT_YET_RECRUITING
Baoding
Beijing GoBroad Hospital
NOT_YET_RECRUITING
Beijing
BEIJING TONGREN HOSPITAL, Capital Medical University
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
People's Hospital of Hunan Province
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Quanzhou First Hospital.Fujian
NOT_YET_RECRUITING
Fujian
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
ZhuJiang Hospital of Southern Medical University（The Second Clinical Medical College）
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
The First Affiliated Hospital, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
The Second Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital & Institute
NOT_YET_RECRUITING
Jinan
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
Jiangsu Cancer Hospital
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Tongji Hospital of Tongji University
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shanxi Provincial Cancer Hospitial
NOT_YET_RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
NOT_YET_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
NOT_YET_RECRUITING
Tianjin
Tianjin People's Hospital
NOT_YET_RECRUITING
Tianjin
Cancer Hospital Affiliated to Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Wuhan Union Hospital of China
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_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