A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT06624085
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Glofitamab — DRUG
    Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
  • Obinutuzumab — DRUG
    Participants will receive IV obinutuzumab pretreatment
  • Gemcitabine — DRUG
    Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
  • Oxaliplatin — DRUG
    Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)

Study Details

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Key Dates

First listed
Oct 2, 2024
Start date
Apr 28, 2025
Status verified
Jul 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Glofitamab + Oxaliplatin
    Participants will receive a single dose of intravenous (IV) obinutuzumab pretreatment 7 days prior to the first dose of glofitamab, followed by up to 8 cycles of glofitamab + gemcitabine + oxaliplatin. This will be followed by up to 4 cycles of glofitamab monotherapy, for a total of up to 12 cycles of glofitamab (cycle length = 21 days).

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: Up to 3 years ]

Central Contacts

  • Reference Study ID Number: GO44900 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (17)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Saddleback Memorial Medical CenterLaguna HillsCalifornia92653-
Hoag Memorial HospitalNewport BeachCalifornia92658-
University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaSanta MonicaCalifornia90404-2023-
Georgetown UniversityWashington D.C.District of Columbia20007-
AdventHealth Cancer InstituteOrlandoFlorida32804-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30329-
University of Illinois Cancer CenterChicagoIllinois60612-
Kansas City VA Medical CenterKansas CityKansas64128-
Walter Reed National Military Medical CenterBethesdaMaryland20814-
Christus Health - Christus St. Vincent Regional Medical CenterSanta FeNew Mexico87505-
Stony Brook Univ Cancer CtrStony BrookNew York11794-
East Carolina UniversityGreenvilleNorth Carolina27834-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Renovatio Clinical - El PasoEl PasoTexas79915-
Baylor College of MedicineHoustonTexas77030-
Renovatio ClinicalThe WoodlandsTexas77380-

Find similar trials in La Jolla, CA

By research site
UC San Diego Moores Cancer Center· La Jolla, CASaddleback Memorial Medical Center· Laguna Hills, CAHoag Memorial Hospital· Newport Beach, CAUniversity of California Los Angeles (UCLA) - Cancer Care - Santa Monica· Santa Monica, CAGeorgetown University· Washington D.C., DCAdventHealth Cancer Institute· Orlando, FL

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