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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

733

Participants

Timeline

Start Date

November 14, 2023

Primary Completion Date

July 29, 2029

Study Completion Date

July 29, 2029

Conditions
Follicular Lymphoma (FL)
Interventions
DRUG

Odronextamab

Administered by intravenous (IV) infusion

DRUG

Rituximab

Administered by IV infusion, or subcutaneous (SC)

DRUG

Cyclophosphamide

Administered by IV infusion

DRUG

Doxorubicin

Administered by IV infusion

DRUG

Vincristine

Administered by IV infusion

DRUG

Prednisone/Prenisolone

Administered orally (PO)

Trial Locations (144)

1000

Institut Jules Bordet, Brussels

1090

Universitatsklinik fur Kinder und Jungendheilkunde, Vienna

2170

Liverpool Hospital, Liverpool

2298

Calvary Mater Newcastle, Waratah

3100

Karl Landsteiner University Hospital St. Poelten, Sankt Pölten

4000

Centre Hospitalier Regional de la Citadelle, Liège

4020

Kepler University Hospital, Linz

4217

Pindara Private Hospital, Benowa

4600

Klinikum Wels-Grieskirchen, Wels

6020

Innsbruck Medical University, Innsbruck

8000

Algemeen Ziekenhuis St Jan Brugge Oostende Av, Bruges

8036

Medical University of Graz, Graz

8500

AZ Groeninge, Kortrijk

8700

Landeskrankenhaus Hochsteiermark, Leoben

9000

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital, Ghent

9100

Verenigde Ziekenhuizen van Waas en Durme, Sint-Niklaas

10137

Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin, Turin

10330

Chulalongkorn University, Bangkok

11217

Taipei Veterans General Hospital, Taipei

11490

Tri-Service General Hospital, Taipei

11590

Clinical Research Alliance Inc, Westbury

11696

Taipei Medical University Multipal Wan Fang University, Taipei

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20141

Istituto Europeo di Oncologia, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda - Main Address, Milan

23561

Taipei Medical University - Shuang Ho Hospital, New Taipei City

24116

Stadtisches Krankenhaus Kiel, Kiel

27003

Hospital Universitario Lucus Augusti, Lugo

28027

Clinica Universidad de Navarra - Madrid, Madrid

28031

Hospital Universitario Infanta Leonor, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda

28223

Hospital Universitario Quiron Salud Madrid, Pozuelo de Alarcón

30029

Institut de Cancerologie du Gard, Nîmes

31008

Hospital Universitario de Navarra, Pamplona

Clinica Universidad de Navarra- Pamplona, Pamplona

32005

Complexo Hospitalario Universitario de Ourense, Ourense

33011

Hospital Universitario Central de Asturias, Oviedo

33100

Azienda Sanitaria Universitaria del Friuli Centrale, Udine

33200

VM Medical Park Mersin Hospital, Mezitli

33322

Boca Raton Clinical Research (BRCR) Global, Plantation

33600

Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque, Pessac

34365

VKV American Hopital, Istanbul

34418

Istanbul University, Istanbul

37007

Hospital Universitario de Salamanca, Salamanca

37044

CHRU de Tours, Tours

38039

Erci̇yes Uni̇versi̇ty, Kayseri

38043

Centre Hospitalier Universitaire de Grenoble, Grenoble

38408

Centro Oncologico do Triangulo (COT) - Uberlandia, Uberlândia

40002

Khon Kaen University, Khon Kaen

40024

Centre Hospitalier de Mont-de-Marsan, Mont-de-Marsan

40536

University of Kentucky, Lexington

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41124

A.O.U. di Modena, Modena

41462

MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH, Neuss

42055

CHU de Saint-Etienne, Saint-Etienne

42123

Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova, Reggio Emilia

43012

Centre Hospitalier Emile Roux, Le Puy-en-Velay

44093

Nantes University Hospital, Nantes

44600

Centre Hospitalier de Saint Nazaire, Saint-Nazaire

46009

Instituto Valenciano de Oncologia, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

46062

Investigative Clinical Research of Indiana, Noblesville

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48121

UO Ematologia Ravenna, Ravenna

48202

Henry Ford Health System, Detroit

48903

Cruces University Hospital (Hospital Universitario Cruces), Barakaldo

49100

Rabin Medical Center, Petah Tikva

49503

Cancer and Hematology Centers of Western Michigan, Grand Rapids

50005

University Hospital Hradec Kralove, Hradec Králové

53188

Prohealth Care Inc, Waukesha

54050

Sakarya University, Sakarya

55270

Ondokuz Mayıs University, Samsun

56126

University of Pisa, Section of Hematology, Pisa

59100

Tekirdag Namik Kemal University Hospital, Tekirdağ

60185

Aidport, Skorzewo

62300

Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens), Lens

62500

University Hospital Brno, Brno

64239

The Tel Aviv Sourasky Medical Center, Tel Aviv

67100

Zonguldak Bulent Ecevit University, Zonguldak

75010

Hopital Saint Louis, Paris

77030

Center for Oncology and Blood Disorders, Houston

80131

Federico II University, Napoli

80756

Kaohsiung Medical University Hospital, Kaohsiung City

83301

Chang Gung Memorial Hospital Kaohsiung, Kaohsiung City

84101

Soroka University Medical Center, Beersheba

84405

Community Cancer Trials of Utah, Ogden

85100

Azienda Ospedaliera Regionale San Carlo, Potenza

90127

Azienda Ospedaliera Universitario Policlinico Palermo, Palermo

91200

Hadassah Medical Center, Jerusalem

95100

Hopital Victor Dupouy Argenteuil, Argenteuil

95300

The Novo Hospital North West Val Deoise, Cergy-Pontoise

3109601

Rambam Health Care Campus, Haifa

6971028

Assuta Medical Centers, Tel Aviv

7550000

Pontificia Universidad Catolica de Chile, Santiago

7560907

Centro Oncologia de Precision Universidad Mayor, Santiago

7580206

Inmunocel, Santiago

7620157

Hospital Clinico Universidad de Los Andes, Santiago

9103102

Shaare Zedek Medical Center, Jerusalem

14048900

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto, Ribeirão Preto

17210080

Amaral Carvalho Hospital, Jaú

20231050

Instituto Nacional dCancer Jose Alencar Gomes da Silva, Rio de Janeiro

30380472

Instituto Mario Pena de Ensino Pesquisa e Inovacao, Belo Horizonte

41253900

Hospital Sao Rafael, Salvador

41950640

Ensino e Terapia de Inovacao Clinica Amo (Etica), Salvador

89201260

Centro de Hematologia e Oncologia, Joinville

90035903

Hospital de Clinicas de Porto Alegre, Porto Alegre

40050-410

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia, Salvador

70200-730

Hospital Sirio Libanes Brasilia, Brasília

70390-140

Instituto DOr de Pesquisa e Ensino Df Star, Brasília

81520-060

Hospital Erasto Gaertner, Curitiba

59062-000

Liga Norte Riograndense Contra o Cancer, Natal

95700-084

Instituto Tacchini de Pesquisa em Saude, Bento Gonçalves

99010-080

Instituto do Cancer em Hospital Sao Vicente de Paulo, Passo Fundo

88501-001

Animi Unidade de Tratamento Oncologico Ltda, Lages

14784-400

Fundacao Pio XII Hospital de Amor, Barretos

01323-903

Hospital Alemao Oswaldo Cruz, São Paulo

01509010

AC Camargo Cancer Center, São Paulo

05403-000

Clinical Hospital of Medicine School at Sao Paulo University, São Paulo

08270-070

Casa de Saude Santa Marcelina, São Paulo

06400

Cannes Hospital (Centre Hospitalier Cannes Simone Veil), Cannes

06132

Azienda Ospedaliera di Perugia, Perugia

00161

Azienda Osperdaliero-Universitaria Policlinico Umberto 1, Rome

30-510

Matopolskie Centrum Medyczne S.C., Krakow

85-168

Szpital Uniwersytecki Nr2 Bydgoszcz, Bydgoszcz

80-952

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

40-519

Pratia Onkologia Katowice, Katowice

93-513

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

20-954

Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin

02781

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa, Warsaw

58-300

Szpital Szpecjalistyczny w Walbrzychu, Wałbrzych

08208

Parc Tauli Sabadell Hospital Universitari, Sabadell

08221

Hospital Universitari Mutua Terrassa, Terrassa

03010

Hospital General Universitario Doctor Balmis Alicante, Alicante

06200

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Yenimahalle

06100

Gazi University, Ankara

Liv Hospital Ankara, Ankara

TR1 3LJ

Royal Cornwall Hospital, Truro

UB8 3NN

The Hillingdon Hospitals NHS Foundation Trust, Uxbridge

B15 2SY

University Hospitals Birmingham NHS Foundation Trust, Birmingham

AB25 2ZN

NHS Grampian: Aberdeen Royal Infirmary, Aberdeen

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY

NCT06097364 - A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma | Biotech Hunter | Biotech Hunter