Non Hodgkin Lymphoma Clinical Trial

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Summary

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"), have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory").

This study will be made up of Part 1a, Part 1b, and Part 2.The aim of Part 1a and Part 1b of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.

The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy, the current standard of care treatment approved for Non-Hodgkin's lymphoma (NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug when combined with chemotherapy
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
The impact from the study drug on your quality of life and ability to complete routine daily activities

View Eligibility Criteria

Eligibility Criteria

KEY Inclusion Criteria:

Previously untreated participants for lymphoma with documented cluster of differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL (Part 1A only)
Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy ≥ 12 months
International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only;
Adequate hematologic and organ function, as defined in the protocol.

KEY Exclusion Criteria:

Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
Another active malignancy, significant active disease or medical condition, as described in the protocol
Peripheral neuropathy Grade ≥3
Treatment with any systemic anti-lymphoma therapy
Any investigational therapy within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
Allergy/hypersensitivity to study drugs, as described in the protocol
Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

904

Study ID:

NCT06091865

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 64 Locations for this study

See Locations Near You

UC Irvine Health Chao Family Comprehensive Cancer Cente
Orange California, 92868, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis Indiana, 46202, United States
Clinical Research of Indiana
Noblesville Indiana, 46062, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids Michigan, 49503, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States More Info
Matthew Matasar
Principal Investigator
Stony Brook University Hospital
Stony Brook New York, 11794, United States
Clinical Research Alliance Inc
Westbury New York, 11590, United States
Center For Oncology and Blood Disorders
Houston Texas, 77030, United States
The Community Cancer Trials
Ogden Utah, 84405, United States
ProHealth Care Inc
Waukesha Wisconsin, 53188, United States More Info
Timothy Wassenaar
Principal Investigator
Icon Cancer Centre
Auchenflower Queensland, 4066, Australia
Epworth Freemasons
East Melbourne Victoria, 3121, Australia
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Gent Oost-Vlaanderen, 9000, Belgium
AZ Delta
Roeselare West Flanders, 8800, Belgium
Az st Elizabeth
Herentals , 2200, Belgium
CHR de Verviers
Verviers , 4800, Belgium
Inmunocel
Santiago Region Metropolitana, 75802, Chile
Clinica Alemana de Santiago
Santiago Región Metropolitana, 76505, Chile
University Hospital Hradec Kralove
Hradec Kralove 5 , 50005, Czechia
CHRU de Tours
Tours Centre Val De Loire, 37044, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux Cedex Gironde, 33077, France
Hôpital Saint Vincent-de-Paul
Lille cedex Nord, 5900, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac Nouvelle-Aquitaine, F3360, France
Gustave Roussy
Villejuif Paris, 94800, France
Centre Hospitalier Metropole Savoie
Chambery Savoie, 73000, France
Centre Hospitalier Universitaire Angers (CHU Angers)
Angers , 49933, France
CHU Nimes Institut de Cancerologie
Nimes , 30029, France
Saint Antoine Hospital
Paris , 75571, France
CHU de Saint-Etienne
Saint-Etienne , 42055, France
Hopital Victor Dupouy Argenteuil
Argenteuil Île De France, 95100, France
Istituto Scientifico Romagnolo per lo Studio e la Cura dei tumori
Meldola (fc) Forli-Cesena, 47014, Italy
ASST Monza Ospedale San Gerardo
Monza , 20900, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara , 28100, Italy
Ospedale Santa Maria delle Croci
Ravenna , 48121, Italy
Dong-A University Hospital
Busan , 49201, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Yeyungnam University Medical Center
Daegu , 42415, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
Malopolskie Centrum Medyczne
Krakow Malopolskie, 30-51, Poland
Pratia Poznan Medical Center
Poznan Wielkopolska, 60185, Poland
Tan Tock Seng Hospital
Singapore , 30843, Singapore
Son Espases University Hospital
Palma Balearic Islands, 07120, Spain
Hospital Universitari Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital Universitari Mutua Terrassa
Terrassa Barcelona, 08221, Spain
Hospital Universitario Marques de Valdecilla
Santander Cantabria, 39008, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón Madrid, 28223, Spain
Hospital Virgen de Las Nieves de Granada
Granada , 18014, Spain
Hospital Universitario Infanta Leonor
Madrid , 28031, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
University Hospital Doctor Peset
Valencia , 46017, Spain
Chulalongkorn University
Bangkok Krung Thep Maha Nakhon [Bangko], 10330, Thailand
Sriraj Hospital
Bangkok , 10700, Thailand
Chiang Mai University
Chiang Mai , 50200, Thailand
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle Ankara, 06200, Turkey More Info
Fevzi Altuntas
Principal Investigator
Tekirdag Namik Kemal University Hospital
Tekirdag Suleymanpasa, 59100, Turkey More Info
Burhan Turgut
Principal Investigator
Gazi Universitesi
Besevler , 6500, Turkey
Istanbul University, Istanbul Faculty of Medicine
Istanbul , 34418, Turkey
Sakarya University Medical Faculty Hematology Department
Sakarya , 54290, Turkey More Info
Tuba Hacibekiroglu
Principal Investigator
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen , AB25 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

904

Study ID:

NCT06091865

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.