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.
Eligible patients will undergo screening and, upon signing an Informed Consent Form, will receive their first dose of SC Mosunetuzumab.
Mosunetuzumab is administered via SC injection without the need for mandatory hospitalization. The first cycle lasts 21 days, followed by subsequent 28-day cycles. In Cycle 1, Mosunetuzumab is given on Day 1 (5 mg), Day 8 (45 mg), and Day 15 (45 mg). From Cycle 2 onward, a single 45 mg dose is administered on Day 1 of each cycle. Treatment continues for up to 8 cycles (approximately 6 months).
Patients will be monitored for disease status according to standard clinical practice. After completing active treatment, they will enter a post-treatment follow-up phase. Premedication with dexamethasone (20 mg) is mandatory in Cycle 1 and optional in later cycles. Acetaminophen and diphenhydramine may also be administered.
All patients will continue study treatment as per the Schedule of Activities or until premature discontinuation. After treatment discontinuation, disease status assessments will occur approximately every 3 months for up to 24 months. During post-treatment follow-up, PET-CT scans for disease evaluation will be performed every 6 months, as applicable. Patients not under active follow-up will be contacted annually to collect data on disease status and survival.
Throughout the trial, the following data will be collected (as applicable): demographics and baseline characteristics (including sex, age, race, height, and weight), medical history, details of initial diagnosis and treatment history, concomitant medications, adverse events (AEs), serious adverse events (SAEs), disease response, and survival status.
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
Single group
Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.
DrugIn this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles.
Primary Endpoint: Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
It refers to the proportion of patients who experience a predefined reduction in tumor size as a result of treatment.
1. Incidence of adverse events (AEs) and abnormal laboratory test results from first dose through 90 days after administration of last dose;
Progression free survival (PFS), complete metabolic response rate (CRR), duration of response (DOR), duration of complete response, time to next systemic anti-lymphoma treatment (TTNT) and overall survival (OS) at 12 and 24 months
Patient reported outcomes (PROs) according to the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) subscale.
Exploratory Biomarker Research Endpoints: Longitudinal measurement of ctDNA in the peripheral blood (PB), before and during treatment, at disease progression, at CR and one year after achievement of CR, as a biomarker for long-term remission
Evaluating the treatment-induced dynamics and molecular signatures of the non-tumor lymphocytic and myeloid compartments, performing consecutive flow cytometry, single cell RNA sequencing (scRNA-seq) and epigenetic studies, and correlation with outcome;
Time points: before and during treatment, at disease progression, at CR and one year after achievement of CR.
Analyzing tumor microenvironment (TME) in lymph nodes pre-treatment at disease progression, at CR and one year after achievement of CR by performing scRNA-seq;
Evaluating the association between patient's microbiome and response to treatment
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Tel-Aviv Sourasky Medical Center
Lead sponsor
Hoffmann-La Roche
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
