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

NCT07409428 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Weili Zhao · Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2028-04-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07409428 on ClinicalTrials.gov