Hoffmann-La Roche
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).
Inclusion Criteria: * Life expectancy at least 12 weeks * Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry * Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease * At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option * Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment * At least one bi-dime…
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).
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.