Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Diffuse Large B-Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-760 | Drug | — | UNRESOLVED |
| HMPL-760 Placebo | Drug | — | UNRESOLVED |
| R-GemOx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The experimental group
- description
- Patients 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.
- interventionNames
- Drug: HMPL-760
- Drug: R-GemOx
- type
- PLACEBO_COMPARATOR
- label
- The control group
- description
- Placebo 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.
- interventionNames
- Drug: HMPL-760 Placebo
- Drug: R-GemOx
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available