Evaluating HMPL-760 with R-GemOx for Relapsed DLBCL

A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma(R/R DLBCL)

This study is testing if a new drug called HMPL-760, when combined with R-GemOx, can help people with relapsed diffuse large B-cell lymphoma feel better compared to a placebo with R-GemOx.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hutchmed (Industry-sponsored)
• Locations: 23 sites (Hefei, Anhui and 22 other locations)
• Trial ID: NCT06601504 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of HMPL-760 in combination with R-GemOx compared to a placebo with R-GemOx in patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is a Phase II randomized, controlled trial that includes a screening period, treatment phase, safety observation, and follow-up for progression-free survival (PFS) and overall survival (OS). The study will measure the efficacy, safety, and pharmacokinetics of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of DLBCL who require further treatment.

Not a fit: Patients with primary or secondary central nervous system lymphoma or significant organ insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory DLBCL.

How similar studies have performed: Other studies have explored similar combinations in DLBCL, showing promising results, but this specific combination is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

1. Sign the Informed consent form(ICF) and be able to follow the requirements of study protocol;
2. Age ≥18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status 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. Toxicities from prior anticancer therapy not resolved to Grade ≤ 1 (except for alopecia and decreased appetite);
8. Clinically significant active infection;

Where this trial is running

Hefei, Anhui and 22 other locations

• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Third Affiliated Hospital,SUNYAT-SEN UNIVERSITY — Guangzhou, Guangdong, China (Recruiting)
• The Second People's Hospital of Shenzhen — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• Affiliated Hospital od Chengde Medical University — Chengde, Hebei, China (Recruiting)
• Wuhan Union Hospital of China — Wuhan, Hebei, China (Not_yet_recruiting)
• Harbin First Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shandong Cancer Hospital & Institute — Jinan, Shandong, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Weili Zhao — Ruijin Hospital
• Study coordinator: Dongmei Chen

Conditions Relapsed/Refractory Diffuse Large B-Cell Lymphoma; R-GemOx; R/R DLBCL; HMPL-760