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