At a glance
ClinicalIndex Comparison Record- ✓CD20+ aggressive lymphoma (DLBCL NOS, high-grade B-cell lymphoma, transformed follicular lymphoma, or follicular lymphoma Grade 3b)
- ✓Relapsed or refractory to at least one prior systemic therapy for aggressive NHL
- ✓If only one prior line of therapy, must be ineligible for autologous stem cell transplant (ASCT)
- ✓Measurable disease
- ✕Prior treatment with mosunetuzumab, other CD20-directed bispecific antibodies, R-GemOx, or Gem-Ox
- ✕Prior polatuzumab vedotin, with specific exceptions for documented responders (PR/CR with no PD within 12 months) or up to 2 bridging doses to CAR-T
- ✕Grade >1 peripheral neuropathy
- ✕CNS involvement of lymphoma (current or past)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
In Brief
A Phase 3 clinical trial evaluating Mosunetuzumab, Polatuzumab vedotin, and 4 other interventions for Non-Hodgkin Lymphoma. Active but no longer recruiting, targeting 208 participants across 52 sites in 13 countries.
Detailed Summary
This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).
Study Details
Timeline
Interventions
Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).
Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.
Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).