This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
478
Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, United States
Johns Hopkins Uni
Baltimore, Maryland, United States
Progression Free Survival (PFS) according to 2014 Lugano Response Criteria
Time frame: From randomization to the first occurrence of disease progression as determined by an independent review committee (IRC) or death from any cause (up to approximately 8.5 years)
PFS as Determined by the Investigator
Time frame: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8.5 years)
Complete Response Rate
Time frame: Up to approximately 8.5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 8.5 years
Overall Survival (OS)
Time frame: From randomization to death from any cause (up to approximately 8.5 years)
Duration of Objective Response (DOR)
Time frame: From the first occurrence of a documented objective response (complete response or partial response) to disease progression or death from any cause, whichever occurs first (up to approximately 8.5 years)
Duration of Complete Reponse (DOCR)
Time frame: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8.5 years)
Time to Deterioration in Physical Functioning and Fatigue, as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Time frame: Up to approximately 8.5 years
Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Time frame: Up to approximately 8.5 years
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 8.5 years
Serum Concentration of M + Len
Time frame: Up to approximately 8.5 years
Area Under the Curve (AUC) of M + Len
Time frame: Up to approximately 8.5 years
Percentage of Participants with Anti-Drug Antibodies (ADAs)
Time frame: Up to approximately 8.5 years
Time to New Anti-Lymphoma Treatment (TTNALT)
Time frame: From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8.5 years)
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University of Michigan Health System
Ann Arbor, Michigan, United States
Cancer & Hematology Center of West Michigan
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
NYU Long Island Hospital
Mineola, New York, United States
NYU Langone Ambulatory Care Center
New York, New York, United States
...and 102 more locations