HMPL-760 with R‑GemOx versus placebo with R‑GemOx for relapsed or refractory diffuse large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double‑blind, placebo‑controlled Phase III trial comparing HMPL‑760 plus R‑GemOx to placebo plus R‑GemOx in patients with relapsed or refractory DLBCL. Participants undergo screening, receive assigned study treatment during the treatment period, and are followed for safety, progression‑free survival, and overall survival. The study also collects pharmacokinetic data to characterize HMPL‑760 exposure. Sites for enrollment include several tertiary hospitals in China.

Why it matters

Who can join: the full rules

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;

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Baoding NO.1 Central Hospital
  Baoding, China Recruiting
• Beijing GoBroad Hospital
  Beijing, China Recruiting
• BEIJING TONGREN HOSPITAL, Capital Medical University
  Beijing, China Recruiting
• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, China Recruiting
• The First Hospital of Jilin University
  Changchun, China Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Weili Zhao — Ruijin Hospital
• Study coordinator: Dongmei Chen, CPL
• Email: dongmeic@hutch-med.com
• Phone: 86-21-20671794

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-dose epcoritamab with GemOx for relapsed/refractory DLBCL

  This trial will test whether adding a low dose of epcoritamab to GemOx chemotherapy helps people with relapsed or refractory diffuse large B‑cell lymphoma who are eligible for autologous stem cell transplant.

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• Comparing BEBT-908 with Rituximab to Standard Chemotherapy for Lymphoma

  This study is testing whether a new treatment called BEBT-908 combined with rituximab can work better than standard chemotherapy for people with relapsed or hard-to-treat diffuse large B-cell lymphoma.

  Recruiting Phase 3 BeBetter Med Inc · Beijing, Beijing Municipality · NCT06792253

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.