RecruitingPhase 3NCT06521255

Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma


Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

244 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment combinations for people with diffuse large B-cell lymphoma (DLBCL) — a type of blood cancer — that has come back or stopped responding. One combination includes tafasitamab and lenalidomide; the other uses rituximab, both combined with gemcitabine and oxaliplatin chemotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed DLBCL (or a related subtype) that has relapsed or is refractory after 1–3 prior treatments - You have at least one measurable area of disease on imaging - You have not had a stem cell transplant, or you are not eligible for one - You are in reasonably good health (ECOG 0–2) - Your organ function is adequate **You may NOT be eligible if...** - You have another active cancer (within the past 3 years) - You have lymphoma in the brain or spinal cord - You have had a prior allogeneic (donor) stem cell transplant - You previously received anti-CD19 treatment or failed gemcitabine/platinum-based therapy - You have serious heart or nerve disease - You have a history of blood clots 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

DRUGTafasitamab

Tafasitmab was infused intravenously

DRUGLenalidomide

Lenalidomide orally

DRUGGemcitabine

Gemcitabine was infused intravenously

DRUGOxaliplatin

Oxaliplatin was infused intravenously

DRUGRituximab

Rituximab was infused intravenously.


Locations(20)

Beijing Hospital

Beijing, China

The First Hospital Of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

Chenzhou No.1 People's Hospital

Chaozhou, China

Sichuan Province People's Hospital

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Guangdong General Hospital

Guangzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Hangzhou First People's Hospital

Hangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Shandong Cancer Hospital and Institute

Jinan, China

Jiangxi Cancer Hospital

Nanchang, China

The First Affiliated Hospital of Nanchang University

Nanjing, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

Tianjin First Central Hospital

Tianjin, China

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, China

The First Affiliated Hospital Wenzhou Medical University

Wenzhou, China

Union Hospital Tongji Medical College

Wuhan, China

Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06521255


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