nctId: NCT06284122 id: MorningLyte briefTitle: Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 acronym: MorningLyte overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-11 date: 2034-04 date: 2024-02-28 date: 2024-03-15 name: The Lymphoma Academic Research Organisation class: OTHER name: Lymphoma Study Association name: Swiss Group for Clinical Cancer Research name: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea briefSummary: 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. conditions: Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 790 type: ESTIMATED name: Mosunetuzumab name: Lenalidomide name: Rituximab name: Obinutuzumab name: Cyclophosphamide name: Doxorubicin name: Vincristin name: Prednisone name: Rituximab name: Obinutuzumab name: Bendamustin measure: Progression Free Survival (PFS) measure: Progression Free Survival (PFS) measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Best Overall Response (CMR + PMR) rate measure: Best Overall Response (CMR + PMR) rate measure: Progression of disease within 2 years (POD24) measure: PFS measure: PFS measure: Event Free Survival (EFS) by Lugano 2014 measure: Event Free Survival (EFS) by Lugano 2014 measure: Time to Next Anti-Lymphoma Treatment (TTNLT) measure: Time to Next Anti-Lymphoma Treatment (TTNLT) measure: Duration of response measure: Duration of response measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Duration of complete response measure: Duration of complete response measure: Overall Survival (OS) measure: Overall Survival (OS) measure: Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs) measure: Incidence and severity of AEs including SAEs and AESIs measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation measure: Incidence of Second Primary Malignancies (SPM) measure: Incidence of Second Primary Malignancies (SPM) measure: anti-drug antibodies (ADA) to mosunetuzumab measure: Time to deterioration in physical functioning measure: Time to deterioration in lymphoma symptoms measure: Maximum serum concentration of mosunetuzumab - Cmax measure: Minimum serum concentration of mosunetuzumab - Cmin measure: Area under the curve of serum concentration of mosunetuzumab - AUC measure: Maximum serum concentration of lenalidomide - Cmax measure: Minimum serum concentration of lenalidomide - Cmin measure: Area under the curve of serum concentration of lenalidomide - AUC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie city: Brugge zip: 8000 country: Belgium name: Sylvia SNAUWAERT, Pr role: CONTACT lat: 51.20892 lon: 3.22424 facility: INSTITUT JULES BORDET - Service Hématologie city: Bruxelles zip: 1070 country: Belgium name: Marie MAEREVOET, MD role: CONTACT lat: 50.85045 lon: 4.34878 facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie city: Bruxelles zip: 1200 country: Belgium name: Eric VAN DEN NESTE, Pr role: CONTACT lat: 50.85045 lon: 4.34878 facility: GRAND HOPITAL DE CHARLEROI - Service Hématologie city: Charleroi zip: 6000 country: Belgium name: Delphine PRANGER, MD role: CONTACT lat: 50.41136 lon: 4.44448 facility: UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie city: Gent zip: 9000 country: Belgium name: Ciel DE WRIENDT, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: CHU DE LIEGE - Service Hématologie city: Liège zip: 4000 country: Belgium name: Christophe BONNET, Pr role: CONTACT lat: 50.63373 lon: 5.56749 facility: CHR VERVIERS - LA TOURELLE - Service Hématologie city: Verviers zip: 4800 country: Belgium name: Gaetan VANSTRAELEN, MD role: CONTACT lat: 50.58907 lon: 5.86241 facility: CHU UCL NAMUR - SITE GODINNE - Service Hématologie city: Yvoir zip: 5530 country: Belgium name: Gilles CROCHET, MD role: CONTACT lat: 50.3279 lon: 4.88059 facility: CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie city: Avignon zip: 84000 country: France name: Hacène ZERAZHI, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: CH DE LA COTE BASQUE - Service Hématologie city: Bayonne zip: 64100 country: France name: Sophie BERNARD, MD role: CONTACT lat: 43.48333 lon: -1.48333 facility: CHU JEAN MINJOZ - Service Hématologie city: Besançon zip: 25030 country: France name: Adrien CHAUCHET, MD role: CONTACT lat: 47.24878 lon: 6.01815 facility: INSTITUT BERGONIE - Service d'Oncologie Médicale city: Bordeaux zip: 33076 country: France name: Fontanet BIJOU, MD role: CONTACT lat: 44.84044 lon: -0.5805 facility: CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie city: Cahors zip: 46005 country: France name: Martin GAUTHIER, MD role: CONTACT lat: 44.4491 lon: 1.43663 facility: CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie city: Chambéry zip: 73011 country: France name: Arthur DONY, MD role: CONTACT lat: 45.56667 lon: 5.93333 facility: CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique city: Clermont-Ferrand zip: 63003 country: France name: Romain GUIEZE, Pr role: CONTACT lat: 45.77966 lon: 3.08628 facility: HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes city: Créteil zip: 94010 country: France name: François LEMONNIER, MD role: CONTACT lat: 48.78333 lon: 2.46667 facility: CHU DIJON BOURGOGNE - Service Hématologie Clinique city: Dijon zip: 21000 country: France name: Amandine DURAND, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: CHD DE VENDEE - Service Hématologie city: La Roche-sur-Yon zip: 85925 country: France name: Nadine MORINEAU, MD role: CONTACT lat: 46.66667 lon: -1.43333 facility: CHU DE GRENOBLE - Service Hématologie city: La Tronche zip: 38700 country: France name: Sylvain CARRAS, MD role: CONTACT lat: 45.20429 lon: 5.73645 facility: HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie city: Lille zip: 59020 country: France name: Sandy AMORIM, MD role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie city: Lille zip: 59037 country: France name: Franck MORSCHHAUSER, Pr role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire city: Limoges zip: 87042 country: France name: Julie ABRAHAM, MD role: CONTACT lat: 45.83153 lon: 1.25781 facility: INSTITUT PAOLI CALMETTES - Service Hématologie city: Marseille zip: 13273 country: France name: Gabriel BRISOU, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: CHU DE MONTPELLIER - Département d'Hématologie Clinique city: Montpellier zip: 34090 country: France name: Guillaume CARTRON, Pr role: CONTACT lat: 43.61092 lon: 3.87723 facility: GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie city: Mulhouse zip: 68100 country: France name: Bernard DRENOU, MD role: CONTACT lat: 47.75 lon: 7.33333 facility: CHU DE NANTES - Service Hématologie city: Nantes zip: 44093 country: France name: Thomas GASTINNE, MD role: CONTACT lat: 47.21725 lon: -1.55336 facility: CENTRE HOSPITALIER DE NIORT - Médecine interne city: Niort zip: 79021 country: France name: Gaëlle OLIVIER, MD role: CONTACT lat: 46.32313 lon: -0.45877 facility: HOPITAL SAINT-LOUIS - Service Hématologie city: Paris zip: 75475 country: France name: Catherine THIEBLEMONT, Pr role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire city: Pessac zip: 33604 country: France name: François-Xavier GROS, MD role: CONTACT lat: 44.81011 lon: -0.64129 facility: CHU LYON-SUD - Hématologie city: Pierre-Bénite zip: 69495 country: France lat: 45.7009 lon: 4.82511 facility: CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie city: Poissy zip: 78303 country: France name: Mohammed BOUDERBALA, MD role: CONTACT lat: 48.92902 lon: 2.04952 facility: CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire city: Poitiers zip: 86021 country: France name: Stéphanie GUIDEZ, MD role: CONTACT lat: 46.58333 lon: 0.33333 facility: CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie city: Pringy zip: 74374 country: France name: Hannah MOATTI, MD role: CONTACT lat: 45.94622 lon: 6.12608 facility: CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie city: Reims zip: 57092 country: France name: Eric DUROT, MD role: CONTACT lat: 49.25 lon: 4.03333 facility: CHU PONTCHAILLOU - Hématologie Clinique city: Rennes zip: 35033 country: France name: Roch HOUOT, Pr role: CONTACT lat: 48.11198 lon: -1.67429 facility: CENTRE HENRI BECQUEREL - Service Hématologie city: Rouen zip: 76038 country: France lat: 49.44313 lon: 1.09932 facility: INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie city: Saint-Cloud zip: 92210 country: France name: Clémentine SARKOZY, MD role: CONTACT lat: 48.84598 lon: 2.20289 facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie city: Saint-Priest-en-Jarez zip: 42270 country: France name: Ludovic FOUILLET, MD role: CONTACT lat: 45.47501 lon: 4.37614 facility: INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique city: Strasbourg zip: 67033 country: France name: Luc-Matthieu FORNECKER, Pr role: CONTACT lat: 48.58392 lon: 7.74553 facility: IUCT ONCOPOLE - Service Hématologie city: Toulouse zip: 31059 country: France name: Loïc YSEBAERT, MD role: CONTACT lat: 43.60426 lon: 1.44367 facility: CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire city: Tours zip: 37044 country: France name: Laurianne DRIEU LA ROCHELLE, MD role: CONTACT lat: 47.38333 lon: 0.68333 facility: CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie city: Valenciennes zip: 59322 country: France name: Sabine TRICOT, MD role: CONTACT lat: 50.35 lon: 3.53333 facility: CHU BRABOIS - Service Hématologie city: Vandœuvre-lès-Nancy zip: 54511 country: France name: Pierre FEUGIER, Pr role: CONTACT lat: 48.65 lon: 6.18333 facility: CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie city: Vannes zip: 56017 country: France name: Antoine BONNET, MD role: CONTACT lat: 47.66667 lon: -2.75 facility: GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique city: Villejuif zip: 94085 country: France name: Vincent RIBRAG, MD role: CONTACT lat: 48.7939 lon: 2.35992 facility: UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III city: Regensburg zip: 93053 country: Germany name: Stephanie MAYER, MD role: CONTACT lat: 49.01513 lon: 12.10161 facility: UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie city: Ulm zip: 89081 country: Germany name: Christian BUSKE, Pr role: CONTACT lat: 48.39841 lon: 9.99155 facility: INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia city: Lisboa zip: 1099 country: Portugal name: Maria GOMES DA SILVA, Pr role: CONTACT lat: 38.71667 lon: -9.13333 facility: HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia city: Salamanca zip: 37007 country: Spain name: Alejandro MARTIN GARCIA-SANCHO, MD role: CONTACT lat: 40.96882 lon: -5.66388 hasResults: False