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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
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).
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)
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)
Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below.
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Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Alta Bates Summit Medical Center
Berkeley, California, United States
WITHDRAWNCity of Hope Cancer Center
Duarte, California, United States
RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGGeorgetown University
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Miami
Coral Gables, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
WITHDRAWNUniversity of Iowa
Iowa City, Iowa, United States
RECRUITING...and 72 more locations
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)
The EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning and symptoms items are scored on a 4-point scale that ranges from "not at all" to "very much," and the global health status and QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent."
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