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

Lenalidomide starting dose is based on patient's creatinine clearance. 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(116)

Krankenhaus der Barmherzigen Brüder Graz - Abteilung Für Innere Medizin I

Graz, Austria

Krems University Hospital - Abteilung Für Innere Medizin 2

Krems, Austria

LKH HOCHSTEIERMARK - Department für Hämato-Onkologie

Leoben, Austria

Kepler Universitaetsklinikum - Univ.-Klinik für Hämatologie und Internistische Onkologie

Linz, Austria

Paracelsus Medical University - 3rd Medical Department

Salzburg, Austria

Univ. Klinikum ST.PÖLTEN - Klinische Abteilung Für Innere Medizin 1

Sankt Pölten, Austria

Medical University of Vienna - Department of Hematology and Hemostaseology

Vienna, Austria

Klinikum Wels-Grieskirchen GMBH - IVth Internal Department

Wels, Austria

Universitätsklinikum Wiener Neustadt - Klinische Abteilung für Innere Medizin III

Wiener Neustadt, Austria

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

HELORA - Hôpital de La Louvière - Site Jolimont - Service Hématologie Clinique

La Louvière, Belgium

CHU DE LIEGE - Service Hématologie

Liège, 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

GESUNDHEITSZENTRUM ST. MARIEN GMBH - Hämatologie/Onkologie

Amberg, Germany

SOZIALSTIFTUNG BAMBERG - KLINIKUM AM BRUDERWALD - Hämatologie und internistische Onkologie

Bamberg, Germany

VIVANTES KLINIKUM AM URBAN - Hämatologie und Onkologie

Berlin, Germany

Helios Klinikum Berlin-Buch - Klinik für Hämatologie und Stammzelltransplantation

Berlin, Germany

CHARITE UNIVERSITATSMEDIZIN BERLIN - Med. Klinik m. S. Hämatologie, Onkologie, Tumorimmunologie

Berlin, Germany

KLINIKUM BREMEN-MITTE - Gesundheit Nord gGmbH - Hämatologisch-Onkologische Tagesklinik

Bremen, Germany

KLINIKUM CHEMNITZ GGMBH - Klinik f. Innere Medizin III

Chemnitz, Germany

UNIVERSITÄTSKLINIK DÜSSELDORF-Klinik für Hämatologie, Onkologie und Klinische Immunologie

Düsseldorf, Germany

UNIVERSITAETSKLINIKUM ESSEN - Klinik f. Hämatologie

Essen, Germany

GOETHE UNIVERSITÄT FRANKFURT - Medizinische Klinik II Onkologie

Frankfurt, Germany

MEDICAL CENTER - UNIVERSITY OF FREIBURG - Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation

Freiburg im Breisgau, Germany

GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizinisched Onkologie

Göttingen, Germany

UNIVERSITATSKLINIKUM HALLE (SAALE) - Klinik für Innere Medizin IV

Halle, Germany

ONKOLOGIE LERCHENFELD - OncoResearch Lerchenfeld GmbH

Hamburg, Germany

KLINIKUM REGION HANNOVER GMBH KLINIK FÜR HÄMATOLOGIE-Onkologie und immunologie

Hanover, Germany

UNIVERSITÄTSKLINIKUM HEIDELBERG - Innere Medizin V

Heidelberg, Germany

Universitätsklinikum des Saarlandes - Klinik für Innere Medizin I - Onkologie, Hämatol. Immun. & Rheumatololgie

Homburg, Germany

UNIVERSITÄTSKLINIKUM JENA-Klinik für Innere Medizin II

Jena, Germany

WESTPFALZ KLINIKUM - Klinik für Innere Medizin I

Kaiserslautern, Germany

UKSH UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - Med. Klinik II - Hämatologie und Onkologie

Kiel, Germany

GEMEINSCHAFTSKLINIKUM MITTELRHEIN GGMBH - Innere Medizin - Hämatologie/Onkologie

Koblenz, Germany

LAKUMED KLINIKUM - Onkologisches und palliativmedizinisches Netzwerk Landshut

Landshut, Germany

UNIVERSITATSKLINIKUM LUBECK - Klinik für Hämatologie und Onkologie

Lübeck, Germany

KLINIKEN MARIA HILF GMBH KRANKENHAUS ST. FRANZISK - Hämatologie, Onkologie & Gastroenterologie

Mönchengladbach, Germany

KLINIKUM GROSSHADERN DER LMU MUNCHEN - Hämatologie und Onkologie allgemein

München, Germany

KLINIKUM RECHTS DER ISAR, III MED KLINIK DER TU - Hämatologie und Onkologie

München, Germany

Gemeinschaftspraxis Fur Hamatologie Und Onkologie

Münster, Germany

Universtatsklinikum Munster

Münster, Germany

BRUEDERKRANKENHAUS ST. JOSEF PADERBORN - Klinik für Hämatologie und Onkologie

Paderborn, Germany

MVZ FÜR HÄMATOLOGIE UND ONKOLOGIE RAVENSBURG GMBH - Hematology

Ravensburg, Germany

UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

Regensburg, Germany

KLINIKUM AM STEINENBERG REUTLINGEN GMBH - Medizinische Klinik I

Reutlingen, Germany

UNIVERSITÄT ROSTOCK - Hämatologie/Onkologie

Rostock, Germany

AGAPLESION DIAKONIEKLINIKUM ROTENBURG - Klinik für Hämatologie, Onkologie und Nephrologie

Rotenburg (Wümme), Germany

UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie

Ulm, Germany

HELIOS UNIVERSITÄTSKLINIKUM WUPPERTAL - Hämatologie und Onkologie

Wuppertal, Germany

UNIVERSITY WURZBURG - Hämatologie

Würzburg, Germany

INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia

Lisbon, Portugal

HOSPITAL UNIVERSITARIO DE ALBACETE-Servicio de Hematologia

Albacete, Spain

HOSPITAL DURAN I REYNALS - ICO Oncologia

Barcelona, Spain

HOSPITAL DE LA SANTA CREU I SANT PAU - Servicio de Hematología

Barcelona, Spain

HOSPITAL VALL D'HEBRON - Hematology Service

Barcelona, Spain

HOSPITAL CLINIC BARCELONA - Hematology department

Barcelona, Spain

HOSPITAL UNIVERSITARIO DR. NEGRIN-Servicio de Hematologia

Las Palmas de Gran Canaria, Spain

HOSPITAL UNIVERSITARIO ARNAU DE VILANOVA - Servicio Hematologia

Lleida, Spain

HOSPITAL UNIVERSITARIO DE LA PRINCESA - Hematología

Madrid, Spain

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON - Servicio de Hematología-UTMO

Madrid, Spain

HOSPITAL 12 DE OCTUBRE - Servicio de Hematología y Hemoterapia

Madrid, Spain

HOSPITAL PUERTA DEL HIERRO - Servicio Hematologia

Madrid, Spain

HOSPITAL UNIVERSITARIO FUNDACION ALCORCON - Consulta de Hematología Hospital de Día Médico

Madrid, Spain

HOSPITAL COSTA DEL SOL MARBELLA - Servicio de hematologia

Marbella, Spain

HOSPITAL CENTRAL ASTURIAS - Servicio de Hematología

Oviedo, Spain

HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia

Salamanca, Spain

HOSPITAL CLINICO DE VALENCIA - Servicio de Hematologia

Valencia, Spain

Oncology Institute of Southern Switzerland (IOSI) - Department of Oncology

Bellinzona, Switzerland

Kantonsspital Graubunden - Departement Innere Medizin Medizinische Onkologie und Hämatologie

Chur, Switzerland

Hôpitaux Universitaires de Genève (HUG) - Hématologie

Geneva, Switzerland

Kantonsspital Baselland - Zentrum Onkologie & Hämatologie

Liestal, Switzerland

Kantonsspital Olten - Hämatologie

Olten, Switzerland

Spital STS AG - Onkologie und Hämatologiezentrum

Thun, Switzerland

HFR Fribourg - Hématologie

Villars-sur-Glâne, Switzerland

Stadtspital Zürich Triemli - Medizinische Onkologie und Hämatologie

Zurich, Switzerland

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NCT06284122

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Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(116)

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