RecruitingPhase 3NCT06284122

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

A Phase III Randomized, Open-label, International, Multicenter Study Evaluating the Efficacy and Safety of Mosunetuzumab Plus Lenalidomide in Comparison to Anti-CD20 Monoclonal Antibody Plus Chemotherapy in Subjects With Previously Untreated FLIPI 2-5 Follicular Lymphoma

Sponsor

The Lymphoma Academic Research Organisation

Enrollment

790 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma

Summary

This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug combination — mosunetuzumab plus lenalidomide — against the standard chemotherapy approach for people with a slow-growing type of blood cancer called follicular lymphoma who have not yet received treatment. **You may be eligible if...** - You have been diagnosed with follicular lymphoma (grade 1, 2, or 3a) confirmed by biopsy and have not yet been treated - Your disease is in a higher-risk category (FLIPI score 2–5) - Your cancer needs treatment now (e.g., large tumors, B symptoms like fever or night sweats, low blood counts, or fluid buildup) - You are 18 or older and in reasonable general health - Your heart, kidneys, and liver are functioning adequately **You may NOT be eligible if...** - You have already received treatment for follicular lymphoma - You have poor organ function or very low blood counts - You are pregnant, planning to become pregnant, or breastfeeding without using effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMosunetuzumab

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

DRUGLenalidomide

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

DRUGRituximab

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

DRUGObinutuzumab

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

DRUGCyclophosphamide

750 mg/m2 Day 1 from C1 to C6

DRUGDoxorubicin

50 mg/m2 Day 1 from C1 to C6

DRUGVincristin

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

DRUGPrednisone

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

DRUGRituximab

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

DRUGObinutuzumab

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

DRUGBendamustin

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

Locations(49)

AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie

Bruges, Belgium

INSTITUT JULES BORDET - Service Hématologie

Brussels, Belgium

UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie

Brussels, Belgium

GRAND HOPITAL DE CHARLEROI - Service Hématologie

Charleroi, Belgium

UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie

Ghent, Belgium

CHU DE LIEGE - Service Hématologie

Liège, Belgium

CHR VERVIERS - LA TOURELLE - Service Hématologie

Verviers, Belgium

CHU UCL NAMUR - SITE GODINNE - Service Hématologie

Yvoir, Belgium

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

Avignon, France

CH DE LA COTE BASQUE - Service Hématologie

Bayonne, France

CHU JEAN MINJOZ - Service Hématologie

Besançon, France

INSTITUT BERGONIE - Service d'Oncologie Médicale

Bordeaux, France

CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie

Cahors, France

CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie

Chambéry, France

CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique

Clermont-Ferrand, France

HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes

Créteil, France

CHU DIJON BOURGOGNE - Service Hématologie Clinique

Dijon, France

CHD DE VENDEE - Service Hématologie

La Roche-sur-Yon, France

CHU DE GRENOBLE - Service Hématologie

La Tronche, France

HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie

Lille, France

CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie

Lille, France

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

Limoges, France

INSTITUT PAOLI CALMETTES - Service Hématologie

Marseille, France

CHU DE MONTPELLIER - Département d'Hématologie Clinique

Montpellier, France

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

Mulhouse, France

CHU DE NANTES - Service Hématologie

Nantes, France

CENTRE HOSPITALIER DE NIORT - Médecine interne

Niort, France

HOPITAL SAINT-LOUIS - Service Hématologie

Paris, France

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

Pessac, France

CHU LYON-SUD - Hématologie

Pierre-Bénite, France

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

Poissy, France

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

Poitiers, France

CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie

Pringy, France

CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie

Reims, France

CHU PONTCHAILLOU - Hématologie Clinique

Rennes, France

CENTRE HENRI BECQUEREL - Service Hématologie

Rouen, France

INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie

Saint-Cloud, France

Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie

Saint-Priest-en-Jarez, France

INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique

Strasbourg, France

IUCT ONCOPOLE - Service Hématologie

Toulouse, France

CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire

Tours, France

CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie

Valenciennes, France

CHU BRABOIS - Service Hématologie

Vandœuvre-lès-Nancy, France

CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie

Vannes, France

GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique

Villejuif, France

UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

Regensburg, Germany

UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie

Ulm, Germany

INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia

Lisbon, Portugal

HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia

Salamanca, Spain

View Full Details on ClinicalTrials.gov

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NCT06284122

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