A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

Sponsor
Hoffmann-La Roche
Study ID
NCT04313608
Phase
PHASE1
Status
Completed

Conditions

  • B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Glofitamab — DRUG
    Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.
  • Gemcitabine — DRUG
    Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
  • Oxaliplatin — DRUG
    Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
  • Mosunetuzumab — DRUG
    Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.
  • Obinutuzumab — DRUG
    Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).

Study Details

This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).

Key Dates

Start date
Jun 4, 2020
Status verified
Sep 2023
Primary completion
Oct 26, 2021
Completion
Oct 26, 2021

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Glofit-GemOx
    Participants will receive up to 8 cycles of Glofit-GemOx (glofitamab in combination with gemcitabine and oxaliplatin) administered in 21-day cycles, followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab.
  • Experimental: Arm B: Mosun-GemOx
    Participants will receive up to 8 cycles of Mosun-GemOx (mosunetuzumab in combination with gemcitabine and oxaliplatin) administered in 21-day cycles.

Primary Outcome Measure

Number of Deaths Due to Adverse Events (AEs) [ Time Frame: Baseline - 90 days after last dose of study treatment ]

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