Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

PHASE3RecruitingINTERVENTIONAL
Enrollment

790

Participants

Timeline

Start Date

June 7, 2024

Primary Completion Date

November 30, 2028

Study Completion Date

April 30, 2034

Conditions
Follicular Lymphoma
Interventions
DRUG

Mosunetuzumab

5 mg (step-up dosing) Day 1 of C1 45 mg Day 8 and Day 15 of C1, 45 mg Day 1 from C2 to C12, 45 mg Day 1 from C13 to C21

DRUG

Lenalidomide

20 mg/day Day 1 to Day 21 from C2 to C12

DRUG

Rituximab

when associated to CHOP IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C20

DRUG

Obinutuzumab

when associated to CHOP 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C18

DRUG

Cyclophosphamide

750 mg/m2 Day 1 from C1 to C6

DRUG

Doxorubicin

50 mg/m2 Day 1 from C1 to C6

DRUG

Vincristin

1.4 mg/m2 (cap cf. below)$ Day 1 from C1 to C6

DRUG

Prednisone

100 mg/day Day 1 to Day 5 from C1 to C6

DRUG

Rituximab

when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C18

DRUG

Obinutuzumab

when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C20

DRUG

Bendamustin

90 mg/m2 Day 1 and Day 2 from C1 to C6

Trial Locations (49)

1070

RECRUITING

INSTITUT JULES BORDET - Service Hématologie, Brussels

1099

RECRUITING

INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia, Lisbon

1200

RECRUITING

UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie, Brussels

4000

RECRUITING

CHU DE LIEGE - Service Hématologie, Liège

4800

RECRUITING

CHR VERVIERS - LA TOURELLE - Service Hématologie, Verviers

5530

RECRUITING

CHU UCL NAMUR - SITE GODINNE - Service Hématologie, Yvoir

6000

RECRUITING

GRAND HOPITAL DE CHARLEROI - Service Hématologie, Charleroi

8000

RECRUITING

AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie, Bruges

9000

RECRUITING

UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie, Ghent

13273

RECRUITING

INSTITUT PAOLI CALMETTES - Service Hématologie, Marseille

21000

RECRUITING

CHU DIJON BOURGOGNE - Service Hématologie Clinique, Dijon

25030

RECRUITING

CHU JEAN MINJOZ - Service Hématologie, Besançon

31059

RECRUITING

IUCT ONCOPOLE - Service Hématologie, Toulouse

33076

RECRUITING

INSTITUT BERGONIE - Service d'Oncologie Médicale, Bordeaux

33604

RECRUITING

CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire, Pessac

34090

RECRUITING

CHU DE MONTPELLIER - Département d'Hématologie Clinique, Montpellier

35033

RECRUITING

CHU PONTCHAILLOU - Hématologie Clinique, Rennes

37007

RECRUITING

HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia, Salamanca

37044

RECRUITING

CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire, Tours

38700

RECRUITING

CHU DE GRENOBLE - Service Hématologie, La Tronche

42270

RECRUITING

Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie, Saint-Priest-en-Jarez

44093

RECRUITING

CHU DE NANTES - Service Hématologie, Nantes

46005

RECRUITING

CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie, Cahors

54511

RECRUITING

CHU BRABOIS - Service Hématologie, Vandœuvre-lès-Nancy

56017

RECRUITING

CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie, Vannes

57092

RECRUITING

CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie, Reims

59020

RECRUITING

HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie, Lille

59037

RECRUITING

CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie, Lille

59322

RECRUITING

CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie, Valenciennes

63003

RECRUITING

CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique, Clermont-Ferrand

64100

RECRUITING

CH DE LA COTE BASQUE - Service Hématologie, Bayonne

67033

RECRUITING

INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique, Strasbourg

68100

RECRUITING

GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie, Mulhouse

69495

RECRUITING

CHU LYON-SUD - Hématologie, Pierre-Bénite

73011

RECRUITING

CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie, Chambéry

74374

RECRUITING

CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie, Pringy

75475

RECRUITING

HOPITAL SAINT-LOUIS - Service Hématologie, Paris

76038

RECRUITING

CENTRE HENRI BECQUEREL - Service Hématologie, Rouen

78303

RECRUITING

CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie, Poissy

79021

RECRUITING

CENTRE HOSPITALIER DE NIORT - Médecine interne, Niort

84000

RECRUITING

CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie, Avignon

85925

RECRUITING

CHD DE VENDEE - Service Hématologie, La Roche-sur-Yon

86021

RECRUITING

CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire, Poitiers

87042

RECRUITING

CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire, Limoges

89081

RECRUITING

UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie, Ulm

92210

RECRUITING

INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie, Saint-Cloud

93053

RECRUITING

UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III, Regensburg

94010

RECRUITING

HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes, Créteil

94085

RECRUITING

GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique, Villejuif

All Listed Sponsors
collaborator

Lymphoma Study Association

OTHER

collaborator

Swiss Cancer Institute

OTHER

collaborator

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

lead

The Lymphoma Academic Research Organisation

OTHER