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Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

NCT06601504 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-06-06

No results posted yet for this study

Summary

The goal of this study is to evaluate the efficacy 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 (R/R DLBCL).

Conditions

  • Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

DRUG

HMPL-760 planned dose 1

HMPL-760 planned dose 1 daily (QD) orally

DRUG

R-GemOx

R-GemOx regimen includes Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection. R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.

DRUG

HMPL-760 placebo planned dose 1

HMPL-760 placebo planned dose 1 daily (QD) orally

DRUG

HMPL-760 planned dose 2

HMPL-760 planned dose 2 daily (QD) orally

DRUG

HMPL-760 placebo planned dose 2

HMPL-760 placebo planned dose 2 daily (QD) orally

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Weili Zhao · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2026-05-12
Completion
2026-11-12

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 NCT06601504 on ClinicalTrials.gov