NCT07409428

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	HMPL-760	Patients will receive HMPL-760 once daily (QD) orally.
DRUG	HMPL-760 Placebo	Patients will receive HMPL-760 placebo once daily (QD) orally.
DRUG	R-GemOx	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.

Timeline

• Start date: 2026-03-20
• Primary completion: 2028-04-30
• Completion: 2028-12-30
• First posted: 2026-02-13
• Last updated: 2026-04-01

Locations

41 sites across 1 country: China