This is a multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria.
at least 18 years old
Histologically confirmed classic FL (cFL) (according to WHO-HEAM4R classification)
Low tumor burden by GELF criteria
No prior therapy except surgery or radiotherapy for disease that was previously localized
1. An active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by detectable viral DNA in the blood by PCR. Patients with HIV are eligible provided an undetectable viral load and a CD4 count > 200 cell/mcl
Total Bilirubin or GGT or AST or ALT > 3 X ULN.
Creatinine Clearance calculated by Cockcroft and Gault Formula < 40 ml/min
Presence or history of CNS involvement by lymphoma
Tel-Aviv Sourasky Medical Center
Lead sponsor
Hoffmann-La Roche
Collaborator