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

Plain-language summary

This study compares the drug HMPL-760 plus R-GemOx chemotherapy against placebo plus R-GemOx in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Adults aged 18 and over with a histopathologically confirmed diagnosis of DLBCL can take part. The study is being conducted in Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Hutchmed

Intervention

HMPL-760, HMPL-760 Placebo, R-GemOx

Start date

3/20/2026

Estimated completion

12/30/2028

Countries

China

Related genes

Locations

• Shanghai, China
• Baoding, China
• Beijing, China
• Beijing, China
• Bengbu, China
• Changchun, China
• Changsha, China
• Changsha, China
• Changsha, China
• Chengdu, China
• Chengdu, China
• Chongqing, China
• Chongqing, China
• Fujian, China
• Fuzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guiyang, China
• Hangzhou, China
• Hangzhou, China
• Harbin, China
• Hefei, China
• Jinan, China
• Jinan, China
• Kunming, China
• Nanchang, China
• Nanjing, China
• Nanjing, China
• Nanning, China
• Qingdao, China
• Shanghai, China
• Shanghai, China
• Shenyang, China
• Shenzhen, China
• Taiyuan, China
• Tangshan, China
• Tianjin, China
• Tianjin, China
• Tianjin, China

+10

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Sign the ICF and be able to follow the requirements of study protocol;
2. Age ≥18 years;
3. ECOG performance status score between 0 and 2;
4. Histopathologically confirmed diagnosis of DLBCL;
5. The investigator judges that the patient's current condition requires further treatment;
6. Patients should have at least one bi-dimensionally measurable lesion;
7. Expected survival is more than 12 weeks;

Exclusion Criteria:

1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
3. Organ insufficiency;
4. 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);
5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
7. 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);
8. Clinically significant active infection;