RecruitingPhase 3NCT06929624

A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma

A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

280 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study tests whether adding a new drug called SHR-A1912 to a standard chemotherapy regimen (R-GemOx) improves outcomes for people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or is not responding to treatment. **You may be eligible if...** - You are 18 to 79 years old - You have been diagnosed with DLBCL confirmed by a tissue sample - You have received at least one prior course of cancer treatment - You have at least one measurable tumor - You are in reasonably good health with a life expectancy of at least 3 months **You may NOT be eligible if...** - Your lymphoma involves the central nervous system (brain or spinal cord) - You have a specific subtype called primary mediastinal large B-cell lymphoma - You have a history of immunodeficiency - You have had another type of cancer in the past 5 years - You have serious heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1912 Injection

SHR-A1912 injection.

DRUGRituximab Injection

Rituximab injection.

DRUGGemcitabine Hydrochloride for Injection

Gemcitabine hydrochloride for injection.

DRUGOxaliplatin Injection

Oxaliplatin injection.


Locations(2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06929624


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