An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Hoffmann-La Roche
Study ID
NCT06047080
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Participants will receive intravenous (IV) glofitamab
  • Polatuzumab vedotin — DRUG
    Participants will receive IV polatuzumab vedotin in combination with R-CHP
  • Rituximab — DRUG
    Participants will receive IV rituximab
  • Cyclophosphamide — DRUG
    Participants will receive cyclophosphamide as part of CHP chemotherapy
  • Doxorubicin — DRUG
    Participants will receive IV doxorubicin
  • Prednisone — DRUG
    Participants will receive oral prednisone as part of CHP chemotherapy

Study Details

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Key Dates

Start date
Sep 18, 2023
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Oct 30, 2030

Study Design

Enrollment
1,130 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab + Pola-R-CHP
    Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
  • Active Comparator: Pola-R-CHP
    Participants will receive Pola-R-CHP.

Primary Outcome Measure

Progression-free survival (PFS) as determined by Independent Review Facility (IRF) [ Time Frame: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months) ]

Locations (60)

FacilityCityStateZIPSite coordinators
Alaska Oncology & Hematology, LLCAnchorageAlaska99508-
Kaiser Permanente - Anaheim (E. La Palma)AnaheimCalifornia92806-
University of California, San Francisco-FresnoClovisCalifornia93611-
City of Hope National Medical CenterDuarteCalifornia91010-
City of Hope - Lennar Foundation Cancer CenterIrvineCalifornia92618-
UCLA Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Kaiser Permanente - RosevilleRosevilleCalifornia95661-
Kaiser Permanente - Santa ClaraSanta ClaraCalifornia95051-
Stanford Univ School of MedStanfordCalifornia94305-5821-
Kaiser Permanente Medical CtrVallejoCalifornia94589-
University of Colorado Cancer CenterAuroraColorado80045-
Rocky Mountain Cancer Center - DenverLittletonColorado80120-
Yale University School Of MedicineNew HavenConnecticut06519-
Medstar Franklin Square Medical CenterWashington D.C.District of Columbia20010-
Miami Cancer Institute of Baptist Health, Inc.MiamiFlorida33176-
Memorial Cancer Institute at Memorial WestPembroke PinesFlorida33028-
Hawaii Cancer CareHonoluluHawaii96813-
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois60637-1447-
Illinois Cancer CarePeoriaIllinois61615-
Springfield ClinicSpringfieldIllinois62702-
University of IowaIowa CityIowa52242-
Ascension Via Christi ResearchWichitaKansas67214-
Ochsner Medical CenterNew OrleansLouisiana70121-
Boston Medical CenterBostonMassachusetts02218-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemNoviMichigan48377-3600-
M Health Fairview University of Minnesota Medical CenterMinneapolisMinnesota55455-
St. Luke's HospitalChesterfieldMissouri63017-
Washington University School of MedicineSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-0600-
NYU Langone Hospital?BrooklynBrooklynNew York11220-
NYU Long Island HospitalMineolaNew York11501-
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer CareNew YorkNew York10021-
New York University Medical Center PRIMENew YorkNew York10016-
Weill Cornell Medical College-New York Presbyterian HospitalNew YorkNew York10021-
University of Rochester Medical CenterRochesterNew York14642-
North Shore Hematology Oncology Association PCShirleyNew York11967-
Montefiore Medical CenterThe BronxNew York10467-
New York Cancer & Blood SpecialistsThe BronxNew York10469-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Willamette Valley Cancer Insitute and Research CenterSpringfieldOregon97477-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Kimmel Cancer Center Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
West Penn HospitalPittsburghPennsylvania15224-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Greco-Hainesworth Tennessee Oncology Centers for ResearchChattanoogaTennessee37404-
West Cancer Center & Research InstituteGermantownTennessee38138-
Tennessee OncologyNashvilleTennessee37203-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
USOR - Texas Oncology - San Antonio NortheastSan AntonioTexas78217-
University of VermontBurlingtonVermont05401-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Oncology AssociatesNewport NewsVirginia23606-
Swedish Medical CenterSeattleWashington98104-1360-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-
West Virginia UniversityMorgantownWest Virginia26506-
Univ of Wisconsin Hosp & ClinMadisonWisconsin53792-

Find similar trials in Anchorage, AK

By research site
Alaska Oncology & Hematology, LLC· Anchorage, AKKaiser Permanente - Anaheim (E. La Palma)· Anaheim, CAUniversity of California, San Francisco-Fresno· Clovis, CACity of Hope National Medical Center· Duarte, CACity of Hope - Lennar Foundation Cancer Center· Irvine, CAUCLA Jonsson Comprehensive Cancer Center· Los Angeles, CA

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