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

Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the World Health Organization (WHO) 2016 classification12, or classical follicular lymphoma according to the WHO 2022 classification13. Diagnostic tissue must be available for central pathology review, exploratory endpoints and secondary data use. (Patients with absolute lymphocyte count \> 20 G/L must be discussed with the Sponsor before screening/inclusion).

• FLIPI 2-5.

• All Ann Arbor stages (including stage I if FLIPI ≥ 2).

• Must need treatment as evidenced by at least one of the following criteria:

‣ Bulky disease defined as:

⁃ a nodal or extranodal mass/lesion \> 7 cm in its largest diameter or,

⁃ involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \> 3 cm)

⁃ Presence of at least one of the following B symptoms:

⁃ fever (\> 38°C) of unclear etiology

⁃ night sweats

⁃ weight loss greater than 10% within the prior 6 months

⁃ Symptomatic splenomegaly

⁃ Any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal)

⁃ Any one of the following cytopenias due to lymphoma:

⁃ hemoglobin \< 10g/dL (6.25 mmol/L)

⁃ platelets \<100 x 109/L, or

⁃ absolute neutrophil count (ANC) \< 1.5 x 109/L

⁃ Pleural or peritoneal serous effusion (irrespective of cell content)

⁃ β2microglobulin \> ULN or lactate dehydrogenase (LDH) \> ULN

• At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \> 1.0 cm in its longest dimension (and 18F-2-fluoro-2-deoxy-D-glucose (FDG)-avid lesion).

• Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures.

• Must be ≥ 18 years at the time of signing the informed consent form (ICF).

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

• Estimated minimum life expectancy of 3 months.

⁃ Adequate hematological function within 28 days prior to signing informed consent, including:

∙ Absolute neutrophil count (ANC) ≥ 1 x 109/L

‣ Platelet count ≥ 75 x 109/L, or ≥ 30 x 109/L if bone marrow infiltration or splenomegaly

‣ Hemoglobin ≥ 8.0 g/dL (5 mmol/L) unless related to bone marrow infiltration or splenomegaly. Transfusion is allowed before starting treatment (no required window)

⁃ Normal laboratory values:

∙ Measured or estimated creatinine clearance ≥ 40 mL/min calculated by institutional standard method (MDRD or Cockcroft-Gault)

‣ aspartate aminotransferase (AST) or alanine aminotransférase (ALT) ≤ 2.5 x the upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 5 x ULN

‣ Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for patients with Gilbert syndrome), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 3 x ULN

⁃ left ventricular ejection fraction (LVEF) within normal range (i.e. \> 50% as evaluated by Transthoracic Echocardiography or \> 45% as evaluated by isotopic method (MUGA scan)).

⁃ Patients should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin, low molecular weight heparin or direct oral anticoagulants).

⁃ Patients with a curative anticoagulation therapy can be enrolled. A patient with deep vein thrombosis due to compressive syndrome is eligible if a curative anticoagulation therapy has been started at least 1 week before initiating study treatment: low molecular weight heparin possible at treatment onset, then direct oral anticoagulants according to local practices.

⁃ Must be able to adhere to the study visit schedule and other protocol requirements.

⁃ Negative SARS-CoV-2 test within 7 days prior to randomization. Rapid antigen test is also acceptable. If a patient has a positive SARS-CoV-2 test before randomization, another test should be done and be negative within 7 days before initiation of treatment.

⁃ Negative HIV test before randomization, with the following exception:

⁃ Patients with a positive HIV test before randomization are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/ µL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.

⁃ For women of childbearing potential (WOCBP) (refer to section 14.7): must have a negative result for pregnancy test (highly sensitive serum) at screening and within 7 days before initiation of study treatment, and agree to abstain from breastfeeding during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 6 months after the final dose of chemotherapies (if applicable), 12 months after the final dose of rituximab (if applicable), and 18 months after the final dose of obinutuzumab (if applicable).

⁃ For men (refer to section 14.7): Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of chemotherapies (if applicable), 12 months after the final dose of rituximab (if applicable), and 3 months after the final dose of obinutuzumab (if applicable).

⁃ Patient covered by any social security system (France).

⁃ Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators.

Locations
Other Locations
Belgium
AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie
RECRUITING
Bruges
INSTITUT JULES BORDET - Service Hématologie
RECRUITING
Brussels
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
RECRUITING
Brussels
GRAND HOPITAL DE CHARLEROI - Service Hématologie
RECRUITING
Charleroi
UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
RECRUITING
Ghent
CHU DE LIEGE - Service Hématologie
RECRUITING
Liège
CHR VERVIERS - LA TOURELLE - Service Hématologie
RECRUITING
Verviers
CHU UCL NAMUR - SITE GODINNE - Service Hématologie
RECRUITING
Yvoir
France
CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie
RECRUITING
Avignon
CH DE LA COTE BASQUE - Service Hématologie
RECRUITING
Bayonne
CHU JEAN MINJOZ - Service Hématologie
RECRUITING
Besançon
INSTITUT BERGONIE - Service d'Oncologie Médicale
RECRUITING
Bordeaux
CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie
RECRUITING
Cahors
CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie
RECRUITING
Chambéry
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
RECRUITING
Clermont-ferrand
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes
RECRUITING
Créteil
CHU DIJON BOURGOGNE - Service Hématologie Clinique
RECRUITING
Dijon
CHD DE VENDEE - Service Hématologie
RECRUITING
La Roche-sur-yon
CHU DE GRENOBLE - Service Hématologie
RECRUITING
La Tronche
CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie
RECRUITING
Lille
HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie
RECRUITING
Lille
CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire
RECRUITING
Limoges
INSTITUT PAOLI CALMETTES - Service Hématologie
RECRUITING
Marseille
CHU DE MONTPELLIER - Département d'Hématologie Clinique
RECRUITING
Montpellier
GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie
RECRUITING
Mulhouse
CHU DE NANTES - Service Hématologie
RECRUITING
Nantes
CENTRE HOSPITALIER DE NIORT - Médecine interne
RECRUITING
Niort
HOPITAL SAINT-LOUIS - Service Hématologie
RECRUITING
Paris
CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire
RECRUITING
Pessac
CHU LYON-SUD - Hématologie
RECRUITING
Pierre-bénite
CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie
RECRUITING
Poissy
CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire
RECRUITING
Poitiers
CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie
RECRUITING
Pringy
CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie
RECRUITING
Reims
CHU PONTCHAILLOU - Hématologie Clinique
RECRUITING
Rennes
CENTRE HENRI BECQUEREL - Service Hématologie
RECRUITING
Rouen
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
RECRUITING
Saint-cloud
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
RECRUITING
Saint-priest-en-jarez
INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique
RECRUITING
Strasbourg
IUCT ONCOPOLE - Service Hématologie
RECRUITING
Toulouse
CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
RECRUITING
Tours
CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie
RECRUITING
Valenciennes
CHU BRABOIS - Service Hématologie
RECRUITING
Vandœuvre-lès-nancy
CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie
RECRUITING
Vannes
GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique
RECRUITING
Villejuif
Germany
UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
RECRUITING
Regensburg
UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie
RECRUITING
Ulm
Portugal
INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia
RECRUITING
Lisbon
Spain
HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia
RECRUITING
Salamanca
Contact Information
Primary
Julie ASSEMAT
morninglyte@lysarc.org
+33 (0)4 27 01 27 51
Backup
Marion TAYOL
morninglyte@lysarc.org
+33 (0)6 24 70 15 27
Time Frame
Start Date: 2024-06-07
Estimated Completion Date: 2034-04
Participants
Target number of participants: 790
Treatments
Experimental: Mosun-Len
Mosunetuzumab + lenalidomide
Active_comparator: R-CHOP
Rituximab-CHOP
Active_comparator: G-CHOP
Obinutuzumab-CHOP
Active_comparator: R-Benda
Rituximab-Bendamustin
Active_comparator: G-Benda
Obinutuzumab-Bendamustin
Sponsors
Collaborators: Lymphoma Study Association, Swiss Cancer Institute, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Leads: The Lymphoma Academic Research Organisation

This content was sourced from clinicaltrials.gov

Similar Clinical Trials