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NCT06149286PHASE3Recruiting

A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Regeneron Pharmaceuticals

Start Date

12/28/2023

Completion Date

1/23/2029

Summary

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide * 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. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol. 2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment, as described in the protocol. 3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imaging, as described in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate hematologic and organ function, as described in the protocol. 6. All study participants must: 1. Have an understanding that lenalidomide could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide. 3. Agree not to share study medication with another person. 4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide. Key Exclusion Criteria: 1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol. 2. Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL. 3. History of or current relevant CNS pathology, as described in the protocol. 4. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated. 5. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol. 6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol. 7. Active infection as defined in the protocol. Note: Other protocol-defined Inclusion/Exclusion criteria apply

Interventions

DRUG

Odronextamab

DRUG

Lenalidomide

DRUG

Rituximab

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Conditions

Relapsed/Refractory Follicular LymphomaRelapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

Locations

David Geffen School of Medicine at UCLA

Los Angeles, California 90095

United States

Boca Raton Clinical Research (BRCR) Global

Plantation, Florida 33322

United States

Indiana University and Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

Hattiesburg Clinic

Hattiesburg, Mississippi 39401

United States

Dartmouth Cancer Center

Lebanon, New Hampshire 03756

United States

Stony Brook University Hospital

Stony Brook, New York 11794

United States

Clinical Research Alliance Inc

Westbury, New York 11590

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

Pindara Private Hospital

Benowa, Queensland 4217

Australia

Royal Hobart Hospital

Hobart, Tasmania 7000

Australia

Epworth Freemasons

East Melbourne, Victoria 3121

Australia

Ordensklinikum Linz

Linz, Osterreich 4020

Austria

Kepler University Hospital

Linz, Upper Austria 4020

Austria

Medical University Vienna

Vienna, 1090

Austria

Klinikum Wels-Grieskirchen

Wels, 4600

Austria

Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur

Yvoir, Namur 5530

Belgium

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

Ghent, Oost-Vlaanderen 9000

Belgium

Algemeen Ziekenhuis AZ Delta

Roeselare, West-Vlaanderen 8800

Belgium

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, 2060

Belgium

Institut Jules Bordet

Brussels, 1000

Belgium

Hospital Sao Rafael

Salvador, Estado de Bahia 40285-000

Brazil

Hospital Sirio Libanes Brasilia

Brasília, Federal District 70200-730

Brazil

Uopeccan Hospital do Cancer de Cascavel

Cascavel, Paraná 85806-300

Brazil

Hospital Erasto Gaertner

Curitiba, Paraná 81520-060

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Centro Gaucho Integrado

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

Amaral Carvalho Hospital

Jaú, São Paulo 17210-080

Brazil

Instituto Nacional de Cancer Jose Alencar Gomes da Silva

Rio de Janeiro, 20231050

Brazil

Hospital Sirio Libanes

São Paulo, 01308-050

Brazil

A Beneficencia Portuguesa de Sao Paulo, Oncology House

São Paulo, 01321000

Brazil

University Hospital Hradec Kralove

Hradec Králové, East Bohemia 50005

Czechia

Fakultni Nemocnice Brno

Brno, 62500

Czechia

University Hospital Kralovske Vinohrady

Prague, 10034

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 12808

Czechia

Institut Paoli-Calmettes

Marseille, Bouches Du Rhone 13009

France

CHU de Rennes

Rennes, Brittany Region 35033

France

Centre Hospitalier Regional Universitaire de Tours

Tours, Centre-Val de Loire 37044

France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, Gironde 33077

France

Centre Francois Magendie

Pessac, Gironde 33600

France

Hopital Saint Vincent-de-Paul

Lille, Nord 5900

France

Centre Henri Becquerel

Rouen, Normandy 76038

France

Nantes University Hospital

Nantes, Pays de la Loire Region 44093

France

Centre Hospitalier Metropole Savoie

Chambéry, Savoie 73000

France

Centre Hospitalier d'Avignon

Avignon, 84000

France

Centre Hospitalier Universitaire (CHU) Montpellier

Montpellier, 34290

France

Hopital Saint Louis

Paris, 75010

France

Assistance Publique-Hopitaux de Paris (AP-HP)

Paris, 75571

France

Institut Curie

Saint-Cloud, 92210

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

Stauferklinikum

Mutlangen, Baden-Wurttemberg 73557

Germany

Robert-Bosch-Krankenhaus

Stuttgart, Baden-Wurttemberg 70376

Germany

LMU Klinikum

Munich, Bavaria 80337

Germany

TUM Fakultat fur Medizin - Klinikum Rechts der Isar

Munich, Bavaria 81675

Germany

Clinic Frankfurt (Oder)

Frankfurt am Main, Hesse 15236

Germany

Universitatsmedizin der Johannes-Gutenberg Universitat Mainz

Mainz, Rhineland-Palatinate 55131

Germany

University Hospital Halle Saale

Halle, 6120

Germany

Stadtisches Krankenhaus Kiel

Kiel, 24116

Germany

MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH

Neuss, 41462

Germany

Assuta Ashdod Medical Center

Ashdod, 7747629

Israel

Hadassah Medical Center

Jerusalem, 91200

Israel

Galilee Medical Center

Nahariya, 2210001

Israel

Rabin Medical Center

Petah Tikva, 49100

Israel

Chaim Sheba Medical Center

Ramat Gan, 5265601

Israel

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Assuta Medical Centers

Tel Aviv, 6971028

Israel

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli-Cesena 47014

Italy

Ospedale Policlinico San Martino IRCCS

Genoa, Genova 16132

Italy

S Gerardo Hospital

Monza, Monza E Brianza 20900

Italy

A.O.U. Citta della Salute e della Scienza di Torino

Turin, Piedmont 10126

Italy

Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute

Aviano, Pordenone 33081

Italy

Candiolo Cancer Institute, FPO, IRCCS

Candiolo, Torino 10060

Italy

University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

Bologna, 40138

Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123

Italy

ASST Grande Ospedale Metropolitano Niguarda - Main Address

Milan, 20162

Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122

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

Santa Maria della Misericordia

Udine, 33100

Italy

Hospital Sultanah Aminah Jhor Bahru

Johor Bahru, Johor 80100

Malaysia

University of Malaya Medical Centre

Kuala Lumpur, Negeri / Wilayah Persekutuan 50603

Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Sabah 88586

Malaysia

Hospital Ampang

Ampang, Selangor 68000

Malaysia

Subang Jaya Medical Center

Subang Jaya, Selangor 47500

Malaysia

Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu

Wałbrzych, Lower Silesian Voivodeship 58-309

Poland

Uniwersytecki Szpital Kliniczny

Wroclaw, Lower Silesian Voivodeship 50-367

Poland

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych Terapii

Lublin, Lublin Voivodeship 20-090

Poland

Pratia MCM Krakow

Krakow, Malopolska 30-510

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship 80-952

Poland

Pratia Poznan Medical Center

Poznan, Wielkopolska 60185

Poland

Aidport

Skorzewo, Wielkopolska 60185

Poland

Szpital Uniwersytecki Nr2 Bydgoszcz

Bydgoszcz, 85-168

Poland

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)

Lodz, 93-513

Poland

Narodowy Instytut Onkologii

Warsaw, 02-781

Poland

St. Vincents Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do 16247

South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk 54907

South Korea

Gachon University Gil Medical Center

Incheon, Namdong-Gu 21565

South Korea

Inje University Busan Paik Hospital

Busan, 47392

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Yeyungnam University Medical Center

Daegu, 42415

South Korea

Yonsei University Health System

Seoul, 03722

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

Seoul National University Hospital

Seoul, 3080

South Korea

Ulsan University Hospital

Ulsan, 44033

South Korea

University Hospital of Santiago de Compostela

Santiago de Compostela, A Coruna 15706

Spain

Son Espases University Hospital

Palma, Balearic Islands 07120

Spain

Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Barcelona 08908

Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39008

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias 33011

Spain

University Hospital Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Virgen De Las Nieves De Granada

Granada, 18014

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Fundacion Jimenez Diaz University Hospital

Madrid, 28040

Spain

Hospital Universitario12 de Octubre

Madrid, 28041

Spain

Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Hospital Universitario de Salamanca

Salamanca, 37007

Spain

University Hospital Virgen del Rocio

Seville, 41013

Spain

Instituto Valenciano de Oncologia

Valencia, 46009

Spain

University Hospital Doctor Peset

Valencia, 46017

Spain

Chang Gung Medical Foundation Chia Yi Branch

Buzi, Chiayi County 613

Taiwan

Changhua Christian Hospital

Changhua, 500-06

Taiwan

Show Chwan Memorial Hospital

Changhua, 50008

Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, 80756

Taiwan

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, 83301

Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561

Taiwan

National Cheng Kung University Hospital

Tainan, 701

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Tri-Service General Hospital

Taipei, 11490

Taiwan

Taipei Municipal Wan Fang Hospital

Taipei, 116

Taiwan

Chang Gung Memorial Hospital

Taoyuan City, 333

Taiwan

Chulalongkorn University

Bangkok, Krung Thep Maha Nakhon [Bangko] 10330

Thailand

Sriraj Hospital

Bangkok, 10700

Thailand

Chiang Mai University

Chiang Mai, 50200

Thailand

Ankara University Faculty of Medicine

Mamak, Ankara 06620

Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Yenimahalle, Ankara 06200

Turkey (Türkiye)

Gazi University

Ankara, Central Anatolia 06100

Turkey (Türkiye)

VM Medical Park Mersin Hospital

Mezitli, Mersin 33200

Turkey (Türkiye)

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa 59100

Turkey (Türkiye)

Istanbul University, Istanbul Medical Faculty

Istanbul, 34093

Turkey (Türkiye)

Ege University

Izmir, 35100

Turkey (Türkiye)

Dokuz Eylul University

Izmir, 35340

Turkey (Türkiye)

Sakarya University Medical Faculty

Sakarya, 54290

Turkey (Türkiye)

Ondokuz Mayıs University

Samsun, 55270

Turkey (Türkiye)

Zonguldak Bulent Ecevit University

Zonguldak, 67600

Turkey (Türkiye)

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall TR1 3LJ

United Kingdom

Derriford Hospital and the Royal Eye Infirmary

Plymouth, Devon PL6 8DH

United Kingdom

University Hospitals Dorset

Bournemouth, Dorset BH7 7DW

United Kingdom

Salisbury Foundation Trust

Salisbury, Hampshire SP6 2ND

United Kingdom

The Hillingdon Hospital

Uxbridge, Middlesex UB8 3NN

United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, Surrey SM2 5PT

United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, NR31 6LA

United Kingdom

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford, RM7 0AG

United Kingdom

South Warwickshire NHS Foundation Trust

Warwick, CV34 5BW

United Kingdom