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Brief Title: Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
Official Title: 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
Study ID: NCT06284122
Brief 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.
Detailed Description: 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 Follicular Lymphoma International Prognostic Index (FLIPI) 2-5 follicular lymphoma This study is composed of a screening period (up to 6 weeks before randomization, i.e., 42 days), a treatment period (30 months i.e., 125w), a safety follow-up period (90 days i.e., 3 months), and a survival follow-up period (up to 7 years after the last randomized patient). The enrollment will last approximately 34 months. The total duration of the study will be therefore approximately 10 years. Once a patient provides written consent, they may enter the screening phase, with a duration up to 6 weeks prior to randomization and initiation of treatment. Upon completion of the required assessments in the screening phase, and fulfillment of the eligibility criteria, patients will be randomized. Investigators will be requested to indicate their treatment choice among permitted immuno-chemotherapy regimens just before randomization. The treatment period for each patient starts with the first intake. The patients will receive protocol-specified treatments until: * inability to achieve a response at the end of induction phase (at M12 evaluation for experimental arm, and at M6 evaluation for control arms), * relapse or progression of the disease, * withdrawal of consent, * or unacceptable toxicity In the experimental arm, patients will be treated for 1 cycle of 3 weeks for mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide (47 weeks, around 11 months) during the induction phase, and for a maximum of 9 additional cycles of 8 weeks during the maintenance phase (72 weeks, around 17 months), up to around 125 weeks (30 months). Patients should start the maintenance phase 7 to 8 weeks after the start of last induction cycle (C12). In the control arm, patients will be treated for 8 or 6 cycles of 3 or 4 weeks for anti-CD20 mAb +cyclophosphamide-doxorubicine-vincristine-prednisone (CHOP) or anti-CD20 mAb + Bendamustine, respectively, depending on the assigned arm (24 weeks, around 5 months) during the induction phase, and for a maximum of 12 additional cycles of 8 weeks during the maintenance phase (96 weeks, around 22 months), up to around 125 weeks (30 months). Patients should start the maintenance phase, 6 to 7 or 7 to 8 weeks after the start of last induction cycle (C8 or C6). The option to cross-over from the control arm to the experimental arm is not allowed. All randomized patients will be followed for progression-free survival and overall survival using the same schedule. Patients will be followed up from End of treatment evaluation every 3 months during the first two years, then every 6 months during the next 3 years, then yearly until the end of study. The end of study will occur when all randomized patients have been followed-up for survival for at least 7 years (or discontinued study early).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie, Brugge, , Belgium
INSTITUT JULES BORDET - Service Hématologie, Bruxelles, , Belgium
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie, Bruxelles, , Belgium
GRAND HOPITAL DE CHARLEROI - Service Hématologie, Charleroi, , Belgium
UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie, Gent, , 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, Lisboa, , Portugal
HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia, Salamanca, , Spain
Name: Franck MORSCHHAUSER
Affiliation: Lymphoma Study Association
Role: PRINCIPAL_INVESTIGATOR
Name: Christian BUSKE
Affiliation: GLA
Role: PRINCIPAL_INVESTIGATOR