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NCT06091865PHASE3Recruiting

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

Regeneron Pharmaceuticals

Start Date

12/13/2023

Completion Date

9/12/2029

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"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. 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 (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality of life and ability to complete routine daily activities

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only) 2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Life expectancy ≥ 12 months 5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only 6. Adequate hematologic and organ function, as defined in the protocol. Key Exclusion Criteria: 1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology 2. Another active malignancy, significant active disease or medical condition, as described in the protocol 3. Peripheral neuropathy Grade ≥3 4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy. 5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment 6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol 7. Allergy/hypersensitivity to study drugs, as described in the protocol 8. 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

Interventions

DRUG

Odronextamab

DRUG

Rituximab

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Prednisone/Prednisolone

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Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Locations

Mayo Clinic - Arizona

Scottsdale, Arizona 85259

United States

David Geffen School of Medicine at UCLA

Los Angeles, California 90095

United States

University of California Irvine Medical Center

Orange, California 92868

United States

University of California (UC) Davis

Sacramento, California 95817

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

St Vincent Ascension at Peyton Manning Childrens Hospital

Indianapolis, Indiana 46260

United States

Investigative Clinical Research of Indiana

Noblesville, Indiana 46062

United States

University of Kentucky

Lexington, Kentucky 40536

United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Henry Ford Health System

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

Stony Brook University Hospital

Stony Brook, New York 11794

United States

Clinical Research Alliance Inc

Westbury, New York 11590

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

East Carolina University

Greenville, North Carolina 27834

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Center for Oncology and Blood Disorders

Houston, Texas 77030

United States

Community Cancer Trials of Utah

Ogden, Utah 84405

United States

Prohealth Care Inc

Waukesha, Wisconsin 53188

United States

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

Calvary Mater Newcastle

Waratah, New South Wales 2298

Australia

Icon Cancer Centre - Wesley

Auchenflower, Queensland 4066

Australia

Pindara Private Hospital

Benowa, Queensland 4217

Australia

Epworth Freemasons

East Melbourne, Victoria 3121

Australia

Landeskrankenhaus Hochsteiermark

Leoben, Styria 8700

Austria

Kepler University Hospital

Linz, Upper Austria 4020

Austria

Medical University Graz

Graz, 8036

Austria

Medical University of Vienna

Vienna, 1090

Austria

Hanusch Krankenhaus

Vienna, 1140

Austria

Klinikum Wels-Grieskirchen

Wels, 4600

Austria

AZ St.-Elisabeth Herentals vzw

Herentals, Antwerp 2200

Belgium

Centre Hospitalier Regional de Verviers

Verviers, Liege 4800

Belgium

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

Ghent, Oost-Vlaanderen 9000

Belgium

Az Delta

Roeselare, West-Vlaanderen 8800

Belgium

Institut Jules Bordet

Brussels, 1000

Belgium

Hospital Clinico Universidad de Los Andes

Santiago, Las Condes 7620157

Chile

Centro Oncologia de Precision Universidad Mayor

Santiago, Santiago Metropolitan 7560907

Chile

Inmunocel

Santiago, Santiago Metropolitan 7580206

Chile

Clinica Alemana de Santiago

Santiago, 7650568

Chile

University Hospital Hradec Kralove

Hradec Králové, East Bohemia 50005

Czechia

University Hospital Brno

Brno, South Moravian 62500

Czechia

University Hospital Kralovske Vinohrady

Prague, 10034

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 12808

Czechia

Centre Hospitalier de Cornouaille Quimper Concarneau

Quimper, Brittany Region 29107

France

Centre Hospitalier Universitaire (CHU) Rennes

Rennes, Brittany Region 35033

France

CHRU de Tours

Tours, Centre-Val de Loire 37044

France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, Gironde 33077

France

Centre Hospitalier Universitaire (CHU) de Bordeaux

Pessac, New Aquitaine 33600

France

Centre Hospitalier Universitaire De Poitiers

Poitiers, New Aquitaine 86000

France

Hopital Saint Vincent-de-Paul

Lille, Nord 5900

France

Nantes University Hospital

Nantes, Pays de la Loire Region 44093

France

Centre Hospitalier Metropole Savoie

Chambéry, Savoie 73000

France

Centre Hospitalier Universitaire Angers

Angers, 49000

France

Centre Leon Berard

Lyon, 69008

France

Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception

Marseille, 130005

France

Change Annecy

Metz-Tessy, 74374

France

CHU Nimes Institut de Cancerologie

Nîmes, 30029

France

Assistance Publique-Hopitaux de Paris (AP-HP)

Paris, 75571

France

CHU de Saint-Etienne

Saint-Etienne, 42055

France

Hopital Victor Dupouy Argenteuil

Argenteuil, Île-de-France Region 95100

France

Avicenne Hospital

Bobigny, Île-de-France Region 93000

France

Gustave Roussy

Villejuif, Île-de-France Region 94800

France

Robert-Bosch-Krankenhaus

Stuttgart, Baden-Wurttemberg 70376

Germany

Kliniken Ostalb Stauferklinikum Schwab Gmund

Mutlangen, Gmund D-73557

Germany

Clinic Frankfurt (Oder)

Frankfurt am Main, Hesse 15236

Germany

University Hospital Essen

Essen, North Rhine-Westphalia 45122

Germany

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

Mainz, Rhineland-Palatinate 55131

Germany

UKS Homburg

Homburg, Saarland 66421

Germany

Hematological Praxis Dresden

Dresden, Saxony 01307

Germany

Vivantes Klinikum Am Urban

Berlin, 10967

Germany

University Hospital Carl Gustav Carus

Dresden, 01307

Germany

Stadtisches Krankenhaus Kiel

Kiel, 24116

Germany

Beaumont Hospital

Dublin, Leinster D09V2N0

Ireland

St James Hospital and Trinity College Dublin

Dublin, D08

Ireland

The Chaim Sheba Medical Center

Tel Litwinsky, Tel Aviv 5265601

Israel

Samson Assuta Ashdod University Hospital

Ashdod, 7747629

Israel

Bnai Zion Medical Center

Haifa, 31048

Israel

Hadassah Medical Center

Jerusalem, 91200

Israel

Galilee Medical Center

Nahariya, 2210001

Israel

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli-Cesena 47014

Italy

ASST Monza Ospedale San Gerardo

Monza, Monza E Brianza 20900

Italy

Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin

Turin, Piedmont 10137

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

A.O.U. di Modena

Modena, 41124

Italy

Federico II University

Naples, 80131

Italy

AOU Maggiore della Carita

Novara, 28100

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100

Italy

Azienda Ospedaliera di Perugia

Perugia, 06132

Italy

Ospedale Santa Maria delle Croci

Ravenna, 48121

Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128

Italy

Hematology - Città della Salute e della Scienza di Torino

Turin, 10126

Italy

Santa Maria della Misericordia

Udine, 33100

Italy

Ospedale di Circolo e Fondazione Macchi Varese

Varese, 21100

Italy

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur 59100

Malaysia

Hospital Tg Ampuan Afzan

Kuantan, Pahang 25200

Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Sabah 88200

Malaysia

Hospital Ampang

Ampang, Selangor 68000

Malaysia

Subang Jaya Medical Center

Subang Jaya, Selangor 47500

Malaysia

Matopolskie Centrum Medyczne S.C.

Krakow, Lesser Poland Voivodeship 30-510

Poland

Uniwersytecki Szpital Kliniczny

Wroclaw, Lower Silesian Voivodeship 50-367

Poland

Pratia Poznan Medical Center

Poznan, Wielkopolska 60185

Poland

Aidport

Skorzewo, Wielkopolska 60185

Poland

Szpital Uniwersytecki Nr2 Bydgoszcz

Bydgoszcz, 85-168

Poland

Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center

Gdansk, 80-952

Poland

Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-954

Poland

Narodowy Instytut Onkologii

Warsaw, 02-781

Poland

Szpital Szpecjalistyczny w Walbrzychu

Wałbrzych, 58-300

Poland

Wielospecjalistyczne Centrum Onkologii i Traumatologii

Lodz, Łódź Voivodeship 93-510

Poland

National University Hospital Singapore

Singapore, 119074

Singapore

National Cancer Centre of Singapore

Singapore, 168583

Singapore

Tan Tock Seng Hospital

Singapore, 308433

Singapore

Keimyung University Dongsan Hospital

Dalseo-gu, Daegu 42601

South Korea

St. Vincent Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do 16247

South Korea

Gachon University Gil Medical Center

Incheon, Namdong-Gu 21565

South Korea

Inje University Busan Paik Hospital

Busan, 47392

South Korea

Dong-A University Hospital

Busan, 49201

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Yeyungnam University Medical Center

Daegu, 42415

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Yeouido St. Marys Hospital

Seoul, 07345

South Korea

Seoul St Marys Hospital

Seoul, 137-701

South Korea

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna 15706

Spain

Hospital Universitario Virgen del Rocio

Seville, Andalusia 41013

Spain

Son Espases University Hospital

Palma, Balearic Islands 07120

Spain

Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol

Badalona, Barcelona 08916

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 Universitario de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias 33011

Spain

Hospital Sant Pau

Barcelona, 08041

Spain

Institut Catala d'Oncologia

Barcelona, 08908

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

Fundacion Jimenez Diaz University Hospital

Madrid, 28040

Spain

Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital General Universitario de Toledo

Toledo, 45007

Spain

Instituto Valenciano de Oncologia

Valencia, 46009

Spain

University Hospital Doctor Peset

Valencia, 46017

Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026

Spain

Chang Gung Medical Foundation Chia Yi Branch

Buzi, Chiayi County 613

Taiwan

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan, Hunan Province 33305

Taiwan

Changhua Christian Hospital

Changhua, 50006

Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561

Taiwan

Wanfang Hospital

Taipei, 00116

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chulalongkorn University

Bangkok, Krung Thep Maha Nakhon [Bangko] 10330

Thailand

Sriraj Hospital

Bangkok, 10700

Thailand

Chaing Mai University

Chiang Mai, 50200

Thailand

Faculty of Medicine

Khon Kaen, 40002

Thailand

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Yenimahalle, Ankara 06200

Turkey (Türkiye)

VM Medical Park Mersin Hospital

Mezitli, Mersin 33200

Turkey (Türkiye)

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa 59100

Turkey (Türkiye)

Gazi Universitesi

Beşevler, 6500

Turkey (Türkiye)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34418

Turkey (Türkiye)

Ege University

Izmir, 35100

Turkey (Türkiye)

Dokuz Eylul University

Izmir, 35340

Turkey (Türkiye)

Sakarya University Medical Faculty

Sakarya, 54290

Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, 55239

Turkey (Türkiye)

NHS Grampian: Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN

United Kingdom

The Hillingdon Hospitals NHS Foundation Trust

Uxbridge, UB8 3NN

United Kingdom