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ACTIVE NOT RECRUITING
NCT06601504
PHASE2

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

Sponsor: Hutchmed

View on ClinicalTrials.gov

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).

Official title: A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma(R/R DLBCL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2024-11-05

Completion Date

2026-11-12

Last Updated

2025-06-06

Healthy Volunteers

No

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

Locations (16)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Wuhan Union Hospital of China

Wuhan, Hebei, China

Harbin First Hospital

Harbin, Heilongjiang, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China