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Relapsed/Refractory Diffuse Large B-Cell LymphomaPhase 3NCT07409428

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

A Phase 3 study testing HMPL-760 and R-GemOx in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, run by Hutchmed at 50 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HMPL-760 and R-GemOx
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
50 sitesChina
Study dates
20 Mar 2026to 30 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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);
  • The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);
  • Clinically significant active infection;

Trial locations and contacts

50 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dongmei Chen, CPL contact

86-21-20671794

dongmeic@hutch-med.com

50 sites in 1 country

China50 sites, 50 recruiting

  • Baoding NO.1 Central Hospital

    Baoding

    Haiying Yao, 18617789030, haiyingyaobd@163.com

    Haiying Yao

    Recruiting

  • Beijing GoBroad Hospital

    Beijing

    Kai Hu, 15010390336, HK13610956245@163.com

    Kai Hu

    Recruiting

  • BEIJING TONGREN HOSPITAL, Capital Medical University

    Beijing

    Liang Wang, 15001108693, wangliangtrhos@126.com

    Liang Wang

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

    Yanli Yang, 13855249678, Yangyanli0702@126.com

    Yanli Yang

    Recruiting

  • The First Hospital of Jilin University

    Changchun

    Ou Bai, 13039046656, lbl2054@163.com

    Ou Bai

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Hui Zhou, 13975879796, zhouhui9403@126.com

    Hui Zhou

    Recruiting

  • People's Hospital of Hunan Province

    Changsha

    Can Liu, 137 8728 5260, 617170469@qq.com

    Can Liu

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Hongling Peng, 18900766137, Penghongling@aliyun.com

    Hongling Peng

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    Xiaobing Huang, 18981838236, hxb_trial@163.com

    Xiaobing Huang

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu

    Liqun Zou, 18980601027, Clinical_Zou@163.com

    Liqun Zou

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Yao Liu, liuyao101709@163.com

    Yao Liu

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Xin Wang, 925170788@qq.com

    Xin Wang

    Not yet recruiting

  • Quanzhou First Hospital.Fujian

    Fujian

    Xiongpeng Zhu, 13805998581, xiongpengzhu@163.com

    Xiongpeng Zhu

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou

    Jianzhen Shen, 138 0955 2722, doctorsjz@163.com

    Jianzhen Shen

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Xiaojuan Wei, 86 13560097145, jxw919@hotmail.com

    Xiaojuan Wei

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Zhiming Li, 13719189172, lzmsysu@163.com

    Zhiming Li

    Recruiting

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

    Guangzhou

    Yuhua Li, 13533706656, liyuhua2011gz@163.com

    Yuhua Li

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

    Yan Zhang, 86 18984155172, Zhangyan20010802@sina.com

    Yan Zhang

    Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou

    Zhen Cai, 13857190311, czclinicaltrial@163.com

    Zhen Cai

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Haiyan Yang, 2054451461@qq.com

    Haiyan Yang

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Qingyuan Zhang, 13313612989, sy86298276@163.com

    Qingyuan Zhang

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

    Zhimin Zhai, 13855147434, zzzm889@163.com

    Zhimin Zhai

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan

    Shuqian Xu, 18560087013, yoyoshuqian@126.com

    Shuqian Xu

    Not yet recruiting

  • Shandong Cancer Hospital & Institute

    Jinan

    Zengjun Li, 15735178591, zengjunli@163.com

    Zengjun Li

    Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming

    Mingxia Shi, 86 138 8806 0581, shmxia2002@sina.com

    Mingxia Shi

    Not yet recruiting

  • Jiangxi Cancer Hospital

    Nanchang

    Yan Huang, 29265061@qq.com

    Yan Huang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing

    Yan Zhang, 13914712395, zhangyan1106@njmu.edu.cn

    Yan Zhang

    Recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing

    Jingyan Xu, 86 13951969610, xjy1967@sina.com

    Jingyan Xu

    Not yet recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

    Zhigang Peng, 2557382235@qq.com

    Zhigang Peng

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Xia Zhao, 18661803088, Zhaoxia@qdu.edu.cn

    Xia Zhao

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Fangfang Lv, 18017312613, Lvff80@163.com

    Fangfang Lv

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Weili Zhao, 86 13512112076, zwl_trial@163.com

    Weili Zhao

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai

    Ping Li, 13564181131, lilyforever76@126.com

    Ping Li

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Wei Yang, 18940251012, sjyangw@163.com

    Wei Yang

    Not yet recruiting

  • Shenzhen people's hospital

    Shenzhen

    Jihao Zhou, 86 18718678693, zhoujihao@aliyun.com

    Jihao Zhou

    Not yet recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan

    Liping Su, 13835158122, slpsy2022@163.com

    Liping Su

    Recruiting

  • North China University of Science and Technology Affiliated Hospital

    Tangshan

    Zhenyu Yan, 15931508262, hbyzy2011@163.com

    Zhenyu Yan

    Recruiting

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

    Tianjin

    Dehui Zou, 13602100955, zoudehui@ihcams.ac.cn

    Dehui Zou

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Zhengzi Qian, 13702031222, qzz@163.com

    Zhengzi Qian

    Recruiting

  • Tianjin People's Hospital

    Tianjin

    Xingli Zhao, 13752255454, insectzhao@163.com

    Xingli Zhao

    Recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi

    Yan Li, 86 13639935315, liyan232917@139.com

    Yan Li

    Not yet recruiting

  • The First Affiliated Hospital of WMU

    Wenzhou

    Songfu Jiang, 86 15305770033, jiangsongfu@189.cn

    Songfu Jiang

    Not yet recruiting

  • Hubei Cancer Hospital

    Wuhan

    Huijing Wu, 3269614878@qq.com

    Huijing Wu

    Recruiting

  • Wuhan Union Hospital of China

    Wuhan

    Liling Zhang, 15871725926, lily1228@sina.com

    Liling Zhang

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Pengcheng He, 18991232609, hepc_gcp@163.com

    Pengcheng He

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal)

    Xi'an

    Jie Liu, 86 18092662371, lieujie@163.com

    Jie Liu

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Bing Xu, 86 18750918842, xubingzhangjian@126.com

    Bing Xu

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Wei Sang, 86 13645207648, 13645207648@126.com

    Wei Sang

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Keshu Zhou, 13674902391, dr_zkshu23810@163.com

    Keshu Zhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Xudong Zhang, 13633825183, feverxxd@126.com

    Xudong Zhang

    Recruiting

Other trials in China

About this study

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)

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.

Read the detailed description

The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.

The target population of this study includes patients with DLBCL who are relapsed or refractory.

Being tested
HMPL-760, HMPL-760 Placebo, R-GemOx
Keywords
HMPL-760, R-GemOx (rituximab, gemcitabine, and oxaliplatin), R/R DLBCL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMPL-760Drug

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

  • HMPL-760 PlaceboDrug

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

  • R-GemOxDrug

    Also called Rituximab Injection, Gemcitabine Hydrochloride for Injection, Oxaliplatin Injection

    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.

Study groups in NCT07409428
Study groupRoleWhat they receive
The experimental groupExperimentalPatients 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.
Receives: Drug: HMPL-760; Drug: R-GemOx
The control groupPlacebo 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.
Receives: Drug: HMPL-760 Placebo; Drug: R-GemOx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately two years

  2. 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).

    Measured: Up to approximately two years

  3. 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).

    Measured: Up to approximately two years

  4. Overall survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately two years

  5. 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).

    Measured: Up to approximately two years

  6. 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).

    Measured: Up to approximately two years

Secondary outcomes (8)

  1. Independent review committee (IRC)-assessed PFS

    Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).

    Measured: Up to approximately two years

  2. IRC- and investigator-assessed objective response rate (ORR)

    Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR)

    Measured: Up to approximately two years

  3. IRC- and investigator-assessed complete response rate (CRR)

    Complete response (CR) rate is defined as the ratio of patients with who reached complete response (CR)

    Measured: Up to approximately two years

  4. IRC- and investigator-assessed duration of response (DoR)

    For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first

    Measured: Up to approximately two years

  5. IRC- and investigator-assessed clinical benefit rate (CBR)

    Defined as the ratio of patients with complete response (CR), partial response (PR), or stable disease (SD)

    Measured: Up to approximately two years

  6. IRC- and investigator-assessed time to response (TTR)

    Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR)

    Measured: Up to approximately two years

  7. Safety Endpoints

    • Incidence and severity of treatment-emergent adverse events (TEAEs), incidence of treatment-emergent serious adverse events (TESAEs), incidence of TEAEs leading to permanent discontinuation, dose interruption, and dose reduction, and their correlation to study drug. The severity is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE 6.0).
    • Changes in laboratory tests, vital signs, 12-lead ECG, etc.

    Measured: Up to approximately two years

  8. PK characteristics of HMPL-760 in patients with R/R DLBCL when administered in combination with R-GemOx

    including but not limited to steady-state plasma concentrations of HMPL-760 pre-dose [trough concentrations (Ctrough)] and post-dose (C1h and C2h); If possible, a population pharmacokinetic (PPK) model can be used to generate PK parameters. If necessary, it can also be combined with other studies for model analysis.

    If possible, a population pharmacokinetic (PPK) model can be used to generate PK parameters. If necessary, it can also be combined with other studies for model analysis.

    Measured: At the end of Cycle 4 (each cycle is 21 days)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start20 Mar 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07409428
Sponsor's protocol ID
2025-760-00CH1
Status last verified
Jul 2026
First submitted
28 Jan 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HMPL-760 and R-GemOx in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, run by Hutchmed at 50 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongmei Chen, CPL (86-21-20671794, dongmeic@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately two years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07409428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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