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 Follicular Lymphoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

462

Participants

Timeline

Start Date

December 12, 2023

Primary Completion Date

February 19, 2028

Study Completion Date

November 6, 2031

Conditions
Follicular Lymphoma (FL)
Interventions
DRUG

Odronextamab

Administered by intravenous infusion (IV)

DRUG

Rituximab

Rituximab will be administered by IV, or subcutaneously (SC)

DRUG

Cyclophosphamide

Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

DRUG

Doxorubicin

Administered by IV as part of CHOP chemotherapy

DRUG

Vincristine

Administered by IV as part of CHOP, and CVP chemotherapy

DRUG

Prednisone/prednisolone

Administered orally (PO) as part of CVP chemotherapy

DRUG

Bendamustine

Administered by IV as part of chemotherapy (Rituximab-Bendamustine)

Trial Locations (187)

114

Tri-Service General Hospital, Taipei

116

Taipei Municipal Wan Fang Hospital, Taipei

235

Taipei Medical University-Shuang Ho Hospital, New Taipei City

333

Chang Gung Memorial Hospital Linkou, Taoyuan

613

Chang Gung Medical Foundation Chia Yi Branch, Buzi

704

National Cheng Kung University Hospital, Tainan City

1000

Institut Jules Bordet, Brussels

1090

Medical University of Vienna, Vienna

1140

Hanusch Krankenhaus, Vienna

2060

Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp

2170

Ingham Institute, Liverpool

2200

AZ St.-Elisabeth Herentals vzw, Herentals

3004

Alfred Hospital and Monash University, Melbourne

3010

Inselspital Bern University Hospital, Bern

3065

St Vincent's Hospital - Melbourne, Fitzroy

3121

Epworth Freemasons, East Melbourne

3168

Monash Health, Clayton

4010

Ordensklinikum Linz, Linz

4020

Ordensklinikum Linz Gmbh, Elisabethinen, Linz

4031

University Hospital Basel, Basel

4066

Icon Cancer Centre - Wesley, Auchenflower

5020

Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III, Salzburg

5042

Flinders Medical Centre, Bedford Park

5404

Kantonsspital Baden, Baden

7100

Hopital De Jolimont, Haine-Saint-Paul

8401

Kantonsspital Winterthur Medical Oncology, Winterthur

9000

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

9007

Cantonal Hospital St Gallen, Sankt Gallen

10029

Icahn School of Medicine at Mt Sinai, New York

10034

University Hospital Kralovske Vinohrady, Prague

10060

Candiolo Cancer Institute, FPO, IRCCS, Candiolo

10408

Center for Hematologic Malignancy, Goyang-si

11217

Taipei Veterans General Hospital, Taipei

11590

Clinical Research Alliance Inc, Westbury

11794

Stony Brook University Hospital, Stony Brook

12203

Charite Universitatsmedizin Berlin Campus Benjamin Franklin, Berlin

12808

Vseobecna Fakultni Nemocnice, Prague

13005

Hopital de la Conception, Marseille

13009

Institut Paoli Calmettes, Marseille

15006

Complejo Hospitalario Universitario de a Coruna, A Coruña

15236

Clinic Frankfurt (Oder), Frankfurt am Main

15706

University Hospital of Santiago de Compostela, Santiago de Compostela

16132

IRCCS Ospedale Policlinico San Martino, Genoa

16247

St. Vincents Hospital - The Catholic University of Korea, Suwon

16499

Ajou University Hospital, Suwon

18014

Hospital Virgen De Las Nieves De Granada, Granada

20141

Istituto Europeo di Oncologia, Milan

21100

Ospedale dell'Angelo - Varese, Varese

22908

University of Virginia, Charlottesville

23219

Virginia Commonwealth University, Richmond

24116

Stadtisches Krankenhaus Kiel, Kiel

25123

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

27514

University of North Carolina, Chapel Hill

28007

Gregorio Maranon, Madrid

28027

Clinica Universidad de Navarra, Madrid

28040

Fundacion Jimenez Diaz University Hospital, Madrid

28041

University Hospital & Research Institute, Madrid

28050

Hospital Universitario HM Sanchinarro, Servicio de Hematologia, Madrid

28100

AOU Maggiore della Carita-SCDU Ematologia, Novara

28207

Levine Cancer Institute, Charlotte

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

29010

Hospital Universitario Virgen De La Victoria Malaga, Málaga

30008

Morales Meseguer Hospital, Murcia

30120

Hospital Clinico Universitario Virgen De La Arrixaca, El Palmar

31008

Hospital Universitario de Navarra, Pamplona

31048

Bnai Zion Medical Center, Haifa

32005

Complexo Hospitalario Universitario de Ourense, Ourense

33011

Hospital Universitario Central De Asturias, Oviedo

33100

Santa Maria della Misericordia, Udine

33200

VM Medical Park Mersin Hospital, Mezitli

34365

VKV American Hopital, Istanbul

34418

Istanbul University Istanbul Faculty of Medicine, Istanbul

35033

Centre Hospitalier Universitaire (CHU) Rennes, Rennes

35100

Ege University, Izmir

37007

Hospital Universitario de Salamanca, Salamanca

37044

Centre Hospitalier Regional Universitaire de Tours, Tours

37232

Vanderbilt University Medical Center, Nashville

38039

Erci̇yes Uni̇versi̇ty, Kayseri

39008

Hospital Universitario Marques de Valdecilla, Santander

39401

Hattiesburg Clinic, Hattiesburg

40138

Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi, Bologna

40705

Taichung General Veterans Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41013

University Hospital Virgen del Rocio, Seville

41014

Hospital Universitario Virgen de Valme, Seville

44093

Nantes University Hospital, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

46010

Hospital Clinico Universitario Valencia, Valencia

46026

Hospital Universitari and Politecnic La Fe, Valencia

46062

Investigative Clinical Research of Indiana, Noblesville

47014

Istituto Romagnolo Per Lo Studio Dei Tumori, Meldola

48121

UO Ematologia Ravenna, Ravenna

48201

Karmanos Cancer Institute, Detroit

48903

Cruces University Hospital (Hospital Universitario Cruces), Barakaldo

49201

Dong-A University Hospital, Busan

49241

Pusan National University Hospital, Busan

49933

Centre Hospitalier Universitaire Angers, Angers

50005

University Hospital Hradec Kralove, Hradec Králové

50009

Hospital Clinico Lozano Blesa, Zaragoza

53188

Prohealth Care Inc, Waukesha

54290

Sakarya University Medical Faculty, Sakarya

54907

Jeonbuk National University Hospital, Jeonju

55131

Universitatsmedizin der Johannes-Gutenberg Universitat Mainz, Mainz

55239

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

59100

Tekirdag Namik Kemal University Hospital, Tekirdağ

60185

Aidport, Skorzewo

Cm Pratia Poznan, Skorzewo

63100

UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno, Ascoli Piceno

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

67033

Institut de Cancerologie Strasbourg Europe (ICANS), Strasbourg

67100

Zonguldak Bulent Ecevit University, Zonguldak

70376

Robert-Bosch-Krankenhaus, Stuttgart

73039

Pia Fondazione Panico, Tricase

75010

Hopital Saint Louis, Paris

75701

HOPE Cancer Center of East Texas, Tyler

77030

Center for Oncology and Blood Disorders, Houston

80131

Federico II University, Napoli

80756

Chung-Ho Memorial Hospital, Kaohsiung City

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

84112

Huntsman Cancer Institute - Oncology Division, Salt Lake City

85724

University of Arizona Cancer Center, Tucson

86021

Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers

90095

David Geffen School of Medicine at UCLA, Los Angeles

91200

Hadassah Medical Center, Jerusalem

92868

UC Irvine Health, Orange

94800

Gustave Roussy, Villejuif

95100

Hopital Victor Dupouy Argenteuil, Argenteuil

97080

University Hospital Wurzburg, Würzburg

100225

National Taiwan University Hospital, Taipei

755710

Hopital Saint-Antoine, Paris

2210001

Galilee Medical Center, Nahariya

4941492

Rabin Medical Center, Petah Tikva

5265601

Chaim Sheba Medical Center, Ramat Gan

7500921

Fundacion Arturo Lopez Perez, Santiago

7560907

Centro Oncologia de Precision Universidad Mayor, Santiago

7580206

Inmunocel, Santiago

7650620

Clinica Alemana de Santiago, Santiago

7747629

Samson Assuta Ashdod University Hospital, Ashdod

17210080

Amaral Carvalho Hospital, Jaú

20231050

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

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

02215

Beth Israel Deaconess Medical Center, Boston

30380-420

Instituto Mario Pena de Ensino Pesquisa e Inovacao, Belo Horizonte

59062-000

Liga Norte Riograndense Contra o Cancer, Natal

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

14048-900

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

70390-140

Instituto DOr de Pesquisa e Ensino Df Star, Brasília

22793-334

Instituto Americas, Rio de Janeiro

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

T2N 4N2

Tom Baker Cancer Center, Calgary

E2L 4L2

Saint John Regional Hospital, Saint John

J4V2 H1

Cisss de la Monteregie-Centre, Greenfield Park

G1J1Z4

CHU de Quebec - Universite Laval, Québec

J1H 5N4

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

D-73557

Kliniken Ostalb Stauferklinikum Schwab Gmund, Mutlangen

01307

Hematological Praxis Dresden, Dresden

University Hospital Carl Gustav Carus, Dresden

58-309

Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu, Wałbrzych

50-367

Uniwersytecki Szpital Kliniczny, Wroclaw

30-510

Pratia MCM Krakow, Krakow

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

40-519

Pratia Onkologia Katowice, Katowice

93-513

Copernicus Memorial Hospital, Lodz

20-954

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

02-781

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

06591

Seoul St. Mary's Hospital, Seoul

07120

Son Espases University Hospital, Palma

08035

University Hospital Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

500-06

Changhua Christian Hospital, Changhua

06620

Ankara University Faculty of Medicine, Mamak

06200

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Yenimahalle

06100

Gazi University, Ankara

Liv Hospital Ankara, Ankara

TR1 3LQ

Royal Cornwall Hospital NHS Trust, Truro

PL6 8DH

Derriford Hospital and the Royal Eye Infirmary, Plymouth

BH77DW

University Hospitals Dorset, Bournemouth

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NR4 7UY

Norfolk and Norwich University Hospital, Norwich

RM7 0AG

Barking, Havering and Redbridge University Hospitals NHS Trust, Romford

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY

NCT06091254 - 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 Follicular Lymphoma | Biotech Hunter | Biotech Hunter