A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Summary
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
Arms & interventions
- DrugObinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
- DrugGlofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
- DrugRituximab
Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).
- DrugBendamustine
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
- DrugLenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
- DrugTocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Outcome measures
Primary
Progression-free survival (PFS)
Time frame: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
Secondary
Complete response (CR) rate
Time frame: Up to approximately 24 months
Objective response rate (ORR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: From randomization to death from any cause (up to approximately 24 months)
Time to deterioration in physical functioning/fatigue
Time frame: From randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)
Investigator-assessed PFS
Time frame: From randomization to disease progression or death from any cause (up to approximately 24 months)
Investigator-assessed CR rate
Time frame: Up to approximately 24 months
Investigator-assessed ORR
Time frame: Up to approximately 24 months
Duration of Complete Response (DOCR)
Time frame: From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)
Duration of Response (DOR)
Time frame: From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)
Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale
Time frame: Up to approximately 24 months
Time to deterioration in lymphoma symptoms
Time frame: From randomization to the first documentation of a 3-point or more decrease in score as assessed by the FACT-Lym lymphoma subscale (LymS) questionnaire (up to approximately 24 months)
Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LymS
Time frame: Up to approximately 24 months
Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)
Time frame: Up to approximately 24 months
Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS
Time frame: Up to approximately 24 months
Serum concentration of glofitamab
Time frame: Up to approximately 24 months
Incidence of anti-drug antibodies (ADAs)
Time frame: Up to approximately 24 months
Eligibility criteria
Study locations (18)
Alta Bates Summit Medical Center
Berkeley, California, 94704
City of Hope Cancer Center
Duarte, California, 91010
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, 90404-2023
Yale Cancer Center
New Haven, Connecticut, 06520
Georgetown University
Washington D.C., District of Columbia, 20007
University of Miami
Coral Gables, Florida, 33146
Indiana University
Indianapolis, Indiana, 46202
University of Michigan Health System
Ann Arbor, Michigan, 48109
St. Luke's Hospital
Chesterfield, Missouri, 63017
Renown Regional Medical Center
Reno, Nevada, 89502
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
University of Rochester
Rochester, New York, 14642
Medical University of S. Carolina
Charleston, South Carolina, 29425
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Renovatio Clinical - El Paso
El Paso, Texas, 79915
Renovatio Clinical
The Woodlands, Texas, 77380
University of Virginia
Charlottesville, Virginia, 22906
West Virginia University
Morgantown, West Virginia, 26506