A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

NCT06091254 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R1979-HM-22982022-502660-20-00
• Study Type: interventional
• Target: 822
• Locations: 18 countries
• Sites: 185

Brief Summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for 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
• 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)
• How the study drug affects quality of life and ability to complete routine daily activities.

Conditions

Follicular Lymphoma (FL)

Keywords

Non-Hodgkin lymphomas (NHLs); Indolent NHL; B-cells NHL (B-NHL); Follicular lymphoma; Odronextamab

Outcome Measures

Primary Outcomes (4)

• Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab

  Part 1

  Up to 35 days

• Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab

  Part 1

  Up to 2 years

• Severity of TEAEs of odronextamab

  Part 1

  Up to 2 years

• Complete Response at 30 months (CR30) as assessed by independent central review

  Part 2

  Up to 30 months

Secondary Outcomes (28)

• Concentrations of odronextamab in serum

  Up to 30 months

• Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab

  Up to 30 months

• Magnitude of ADAs to odronextamab

  Up to 30 months

• Objective response as assessed by the investigator

  Up to 30 months

• Progression-Free Survival (PFS) as assessed by independent central review

  Up to 5 years

Study Arms (2)

Odronextamab

EXPERIMENTAL

Part 1 is a safety run-in. All participants will receive odronextamab. In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.

Drug: Odronextamab

Rituximab + Investigator's Choice Chemotherapy

ACTIVE COMPARATOR

Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/prednisolone; Drug: Bendamustine

Interventions

Doxorubicin DRUG

Administered per the protocol as part of CHOP chemotherapy

Also known as: Adriamycin

Rituximab + Investigator's Choice Chemotherapy

Vincristine DRUG

Administered per the protocol as part of CHOP, and CVP chemotherapy

Also known as: Oncovin

Rituximab + Investigator's Choice Chemotherapy

Prednisone/prednisolone DRUG

Administered per the protocol as part of CVP chemotherapy

Also known as: Deltasone/Omnipred

Rituximab + Investigator's Choice Chemotherapy

Bendamustine DRUG

Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Also known as: Treanda

Rituximab + Investigator's Choice Chemotherapy

Odronextamab DRUG

Administered per the protocol

Also known as: REGN1979

Odronextamab

Rituximab DRUG

Administered per the protocol

Also known as: Rituxan

Rituximab + Investigator's Choice Chemotherapy

Cyclophosphamide DRUG

Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

Also known as: Cytoxan

Rituximab + Investigator's Choice Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
• Need for treatment as described in the protocol
• Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate bone marrow function and hepatic function, as described in the protocol

You may not qualify if:

• Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
• Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
• Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
• Treatment with any systemic anti-lymphoma therapy
• Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (190)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

RECRUITING

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

RECRUITING

UC Irvine Health

Orange, California, 92868, United States

WITHDRAWN

Investigative Clinical Research of Indiana

Noblesville, Indiana, 46062, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

COMPLETED

Icahn School of Medicine at Mt Sinai

New York, New York, 10029, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Clinical Research Alliance Inc

Westbury, New York, 11590, United States

WITHDRAWN

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28207, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Center for Oncology and Blood Disorders

Houston, Texas, 77030, United States

RECRUITING

HOPE Cancer Center of East Texas

Tyler, Texas, 75701, United States

WITHDRAWN

Huntsman Cancer Institute - Oncology Division

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

WITHDRAWN

Prohealth Care Inc

Waukesha, Wisconsin, 53188, United States

WITHDRAWN

Ingham Institute

Liverpool, New South Wales, 2170, Australia

RECRUITING

Icon Cancer Centre - Wesley

Auchenflower, Queensland, 4066, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Epworth Freemasons

East Melbourne, Victoria, 3121, Australia

RECRUITING

St Vincent's Hospital - Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Alfred Hospital and Monash University

Melbourne, Victoria, 3004, Australia

RECRUITING

Ordensklinikum Linz

Linz, Osterreich, 4010, Austria

RECRUITING

Ordensklinikum Linz Gmbh, Elisabethinen

Linz, 4020, Austria

RECRUITING

Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III

Salzburg, 5020, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Hanusch Krankenhaus

Vienna, 1140, Austria

RECRUITING

AZ St.-Elisabeth Herentals vzw

Herentals, Antwerp, 2200, Belgium

RECRUITING

Hopital De Jolimont

La Louvière, Hainaut, 7100, Belgium

WITHDRAWN

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

WITHDRAWN

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, 2060, Belgium

WITHDRAWN

Institut Jules Bordet

Brussels, 1000, Belgium

WITHDRAWN

Ensino e Terapia de Inovacao Clinica Amo (Etica)

Salvador, Estado de Bahia, 41950640, Brazil

RECRUITING

Instituto Mario Pena de Ensino Pesquisa e Inovacao

Belo Horizonte, Minas Gerais, 30380-420, Brazil

RECRUITING

Liga Norte Riograndense Contra o Cancer

Natal, Rio Grande do Norte, 59062-000, Brazil

RECRUITING

Instituto do Cancer em Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

Centro de Hematologia e Oncologia

Joinville, Santa Catarina, 89201260, Brazil

RECRUITING

Animi Unidade de Tratamento Oncologico Ltda

Lages, Santa Catarina, 88501-001, Brazil

RECRUITING

Fundacao Pio XII Hospital de Amor

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Amaral Carvalho Hospital

Jaú, São Paulo, 17210080, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Instituto DOr de Pesquisa e Ensino Df Star

Brasília, 70390-140, Brazil

RECRUITING

Instituto Nacional de Cancer Jose Alencar Gomes da Silva

Rio de Janeiro, 20231050, Brazil

RECRUITING

Instituto Americas

Rio de Janeiro, 22793-334, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, 01323-903, Brazil

RECRUITING

AC Camargo Cancer Center

São Paulo, 01509010, Brazil

RECRUITING

Clinical Hospital of Medicine School at Sao Paulo University

São Paulo, 05403-000, Brazil

RECRUITING

Casa de Saude Santa Marcelina

São Paulo, 08270-070, Brazil

RECRUITING

Tom Baker Cancer Center

Calgary, Alberta, T2N 4J8, Canada

RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

CHU de Quebec - Universite Laval

Québec, Quebec, G1J1Z4, Canada

RECRUITING

Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, 7500921, Chile

RECRUITING

Centro Oncologia de Precision Universidad Mayor

Santiago, Santiago Metropolitan, 7560907, Chile

WITHDRAWN

Inmunocel

Santiago, Santiago Metropolitan, 7580206, Chile

RECRUITING

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7650620, Chile

RECRUITING

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Vseobecna Fakultni Nemocnice

Prague, 12808, Czechia

RECRUITING

Centre Hospitalier Universitaire (CHU) Rennes

Rennes, Brittany Region, 35033, France

RECRUITING

Centre Hospitalier Regional Universitaire de Tours

Tours, Centre-Val de Loire, 37044, France

RECRUITING

Nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Hopital de la Conception

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

RECRUITING

Centre Hospitalier Universitaire Angers

Angers, 49933, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

Hopital Saint Louis

Paris, 75010, France

RECRUITING

Hopital Saint-Antoine

Paris, 755710, France

RECRUITING

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, 86021, France

RECRUITING

Institut de Cancerologie Strasbourg Europe (ICANS)

Strasbourg, 67033, France

RECRUITING

Hopital Victor Dupouy Argenteuil

Argenteuil, Île-de-France Region, 95100, France

RECRUITING

Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

RECRUITING

Robert-Bosch-Krankenhaus

Stuttgart, Baden-Wurttemberg, 70376, Germany

WITHDRAWN

University Hospital Wurzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Kliniken Ostalb Stauferklinikum Schwab Gmund

Mutlangen, Gmund, D-73557, Germany

RECRUITING

Clinic Frankfurt (Oder)

Frankfurt am Main, Hesse, 15236, Germany

RECRUITING

Universitatsmedizin der Johannes-Gutenberg Universitat Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Hematological Praxis Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Charite Universitatsmedizin Berlin Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

RECRUITING

Stadtisches Krankenhaus Kiel

Kiel, 24116, Germany

RECRUITING

Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, 91200, Israel

RECRUITING

Galilee Medical Center

Nahariya, 2210001, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Istituto Romagnolo Per Lo Studio Dei Tumori

Meldola, Forli Cesena, 47014, Italy

RECRUITING

Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi

Bologna, Italia, 40138, Italy

RECRUITING

Pia Fondazione Panico

Tricase, Lecce, 73039, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

Candiolo Cancer Institute, FPO, IRCCS

Candiolo, Torino, 10060, Italy

RECRUITING

UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno

Ascoli Piceno, 63100, Italy

RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Federico II University

Naples, 80131, Italy

RECRUITING

AOU Maggiore della Carita-SCDU Ematologia

Novara, 28100, Italy

RECRUITING

UO Ematologia Ravenna

Ravenna, 48121, Italy

RECRUITING

Santa Maria della Misericordia

Udine, 33100, Italy

RECRUITING

Ospedale dell'Angelo - Varese

Varese, 21100, Italy

RECRUITING

Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu

Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

RECRUITING

Pratia MCM Krakow

Krakow, Malopolska, 30-510, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-952, Poland

RECRUITING

Aidport

Skorzewo, Wielkopolska, 60185, Poland

RECRUITING

Cm Pratia Poznan

Skorzewo, Wielkopolska, 60185, Poland

COMPLETED

Pratia Onkologia Katowice

Katowice, 40-519, Poland

RECRUITING

Copernicus Memorial Hospital

Lodz, 93-513, Poland

WITHDRAWN

Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-954, Poland

RECRUITING

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

Warsaw, 02781, Poland

WITHDRAWN

Center for Hematologic Malignancy

Goyang-si, Gyeonggi-do, 10408, South Korea

WITHDRAWN

St. Vincents Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

WITHDRAWN

Dong-A University Hospital

Busan, 49201, South Korea

COMPLETED

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

WITHDRAWN

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

WITHDRAWN

University Hospital of Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

RECRUITING

Hospital Universitario Virgen De La Victoria Malaga

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

RECRUITING

Son Espases University Hospital

Palma, Balearic Islands, 07120, Spain

WITHDRAWN

Cruces University Hospital (Hospital Universitario Cruces)

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Complejo Hospitalario Universitario de a Coruna

A Coruña, Galicia, 15006, Spain

WITHDRAWN

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Clinico Universitario Virgen De La Arrixaca

El Palmar, Murcia, 30120, Spain

WITHDRAWN

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

WITHDRAWN

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Virgen De Las Nieves De Granada

Granada, 18014, Spain

RECRUITING

Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Clinica Universidad de Navarra

Madrid, 28027, Spain

WITHDRAWN

Clinica Universidad de Navarra

Madrid, 28027, Spain

RECRUITING

Fundacion Jimenez Diaz University Hospital

Madrid, 28040, Spain

RECRUITING

University Hospital & Research Institute

Madrid, 28041, Spain

RECRUITING

Hospital Universitario HM Sanchinarro, Servicio de Hematologia

Madrid, 28050, Spain

RECRUITING

Morales Meseguer Hospital

Murcia, 30008, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

University Hospital Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

RECRUITING

Hospital General Universitario de Toledo

Toledo, 45007, Spain

WITHDRAWN

Hospital Clinico Universitario Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Universitari and Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Clinico Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

RECRUITING

Cantonal Hospital St Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Winterthur Medical Oncology

Winterthur, Schweiz, 8401, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Chang Gung Medical Foundation Chia Yi Branch

Buzi, Chiayi County, 613, Taiwan

WITHDRAWN

Chang Gung Memorial Hospital Linkou

Taoyuan, Guishan District, 333, Taiwan

RECRUITING

Changhua Christian Hospital

Changhua, 500-06, Taiwan

RECRUITING

Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 235, Taiwan

RECRUITING

Taichung General Veterans Hospital

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital

Taipei, 116, Taiwan

RECRUITING

Ankara University Faculty of Medicine

Mamak, Ankara, 06620, Turkey (Türkiye)

RECRUITING

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

RECRUITING

Gazi University

Ankara, Central Anatolia, 06100, Turkey (Türkiye)

RECRUITING

VM Medical Park Mersin Hospital

Mezitli, Mersin, 33200, Turkey (Türkiye)

RECRUITING

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)

RECRUITING

Liv Hospital Ankara

Ankara, 06100, Turkey (Türkiye)

RECRUITING

VKV American Hopital

Istanbul, 34365, Turkey (Türkiye)

RECRUITING

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34418, Turkey (Türkiye)

RECRUITING

Ege University

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Erci̇yes Uni̇versi̇ty

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Sakarya University Medical Faculty

Sakarya, 54290, Turkey (Türkiye)

RECRUITING

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, 55239, Turkey (Türkiye)

RECRUITING

Zonguldak Bulent Ecevit University

Zonguldak, 67100, Turkey (Türkiye)

RECRUITING

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

RECRUITING

Derriford Hospital and the Royal Eye Infirmary

Plymouth, Devon, PL6 8DH, United Kingdom

WITHDRAWN

University Hospitals Dorset

Bournemouth, Dorset, BH77DW, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Lanarkshire, G12 0YN, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford, RM7 0AG, United Kingdom

RECRUITING

Related Links

• OLYMPIA

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Prednisolone; Methylprednisolone; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): February 7, 2028
• Study Completion (Estimated): November 3, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

ES (29); BE (5); IL (7); FR (12); CH (5); TU (13); DE (9); KR (8); US (20); BR (17); CZ (3); GB (6); TW (12); AU (7); CL (4); CA (5); IT (13); PL (10)