A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05171647
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab — DRUG
    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).
  • Polatuzumab vedotin — DRUG
    Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.
  • Rituximab — DRUG
    Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
  • Gemcitabine — DRUG
    Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
  • Oxaliplatin — DRUG
    Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

Study Details

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).

Key Dates

Start date
Apr 25, 2022
Status verified
May 2026
Primary completion
Feb 17, 2025
Completion
Feb 28, 2027

Study Design

Enrollment
208 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: M+P (Arm A)
    Participants will receive subcutaneous (SC) mosunetuzumab plus intravenous (IV) polatuzumab vedotin (M+P). Mosunetuzumab will be administered on Days 1, 8, and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2-8. Polatuzumab vedotin will be administered on Day 1 of each cycle up to Cycle 6. Cycle length = 21 days.
  • Active Comparator: R-GemOx (Arm B)
    Participants will receive IV rituximab, IV gemcitabine, and IV oxaliplatin (R-GemOx) on Day 1 of each cycle for 8 cycles. Cycle length = 14 days.

Primary Outcome Measure

Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) [ Time Frame: Up to approximately 23.8 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
St. Luke's HospitalChesterfieldMissouri63017-
Ascension Seton Infusion CenterAustinTexas78712-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center· Duarte, CASt. Luke's Hospital· Chesterfield, MOAscension Seton Infusion Center· Austin, TXMD Anderson Cancer Center· Houston, TX

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