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.
1. 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 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.
FLIPI 2-5.
All Ann Arbor stages (including stage I if FLIPI ≥ 2).
At least one bi-dimensionally measurable nodal lesion, defined as > 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as > 10 mm in its longest dimension (and FDG-avid lesion).
Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13
Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment.
Prior localized radiotherapy for the FL.
Prior history of another lymphoma.
The Lymphoma Academic Research Organisation
Lead sponsor
Lymphoma Study Association
Collaborator
Swiss Cancer Institute
Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Collaborator