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Spots Global Cancer Trial Database for Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

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Trial Identification

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

Study Description

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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Franck MORSCHHAUSER

Affiliation: Lymphoma Study Association

Role: PRINCIPAL_INVESTIGATOR

Name: Christian BUSKE

Affiliation: GLA

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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