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)
1 other identifier
interventional
240
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedStudy Start
First participant enrolled
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
April 1, 2026
March 1, 2026
2.1 years
January 28, 2026
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Progression-free survival (PFS)
Investigator-assessed progression-free survival (PFS) Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014). PFS is defined as the time from randomization to PD or death due to any cause, whichever occurs first.
Up to approximately two years
End of treatment (EOT)
Tumor assessment data will continue to be collected. Tumor assessment data collected after end of treatment (EOT) will be used. Tumor assessment data collected during the study and after EOT will be included in the PFS analysis (treatment policy strategy).
Up to approximately two years
Systemic antitumor therapy
Use of other systemic antitumor therapy before PD or death (in the absence of PD):Tumor assessment after use of other systemic antitumor therapy will not be included in the analysis. For patients using other anti-tumor therapy before PD or death (in absence of PD), PFS will be censored at the last evaluable tumor assessment before the use of other systematic anti-tumor therapy (hypothetical strategy).
Up to approximately two years
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Up to approximately two years
systematic anti-tumor therapy
OS data will continue to be collected after the other systematic anti-tumor therapy, and the OS data collected before and after other systematic anti-tumor therapy will be included in analysis (treatment policy strategy).
Up to approximately two years
Premature withdrawal from study treatment
OS data will continue to be collected after the patient's premature withdrawal from study treatment, and the OS data collected during the study treatment and after EOT will be included in analysis (treatment policy strategy).
Up to approximately two years
Secondary Outcomes (8)
Independent review committee (IRC)-assessed PFS
Up to approximately two years
IRC- and investigator-assessed objective response rate (ORR)
Up to approximately two years
IRC- and investigator-assessed complete response rate (CRR)
Up to approximately two years
IRC- and investigator-assessed duration of response (DoR)
Up to approximately two years
IRC- and investigator-assessed clinical benefit rate (CBR)
Up to approximately two years
- +3 more secondary outcomes
Other Outcomes (7)
Biomarker assessment
Up to approximately two years
To explore the metabolite profile of HMPL-760 in combination with R-GemOx in tumor patients
Up to approximately two years
Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760
Up to approximately two years
- +4 more other outcomes
Study Arms (2)
The experimental group
EXPERIMENTALPatients 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.
The control group
PLACEBO COMPARATORPlacebo 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
- Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
- Organ insufficiency;
- Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
- History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
- Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
- Clinically significant active infection;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hutchmedlead
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weili Zhao
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 13, 2026
Study Start
March 20, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share