A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT04408638
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
  • Glofitamab — DRUG
    Participants will receive IV glofitamab for up to 12 cycles.
  • Rituxumab — DRUG
    Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
  • 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.

Study Details

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Key Dates

Start date
Feb 23, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glofit-GemOx
    Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), 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. Treatment is administered in 21-day cycles.
  • Experimental: R-GemOx
    Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.

Primary Outcome Measure

Overall survival (OS), defined as the time from randomization to date of death from any cause [ Time Frame: Up to 5 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300-
Community Cancer Institute (CCI)FresnoCalifornia93720-
Baptist - MD Anderson Cancer CenterJacksonvilleFlorida32207-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-
University of Maryland Medical CenterBaltimoreMaryland21201-
Massachusetts General HospitalBostonMassachusetts02114-
University of Mississippi Medical CenterJacksonMississippi39216-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Duke University Medical CenterDurhamNorth Carolina27705-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCommunity Cancer Institute (CCI)· Fresno, CABaptist - MD Anderson Cancer Center· Jacksonville, FLSidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDUniversity of Maryland Medical Center· Baltimore, MDMassachusetts General Hospital· Boston, MA

Related Studies