A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06091254
Phase
PHASE3
Status
Recruiting
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Conditions

  • Follicular Lymphoma (FL)

Eligibility Criteria

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

Interventions

  • Odronextamab — DRUG
    Administered per the protocol
  • Rituximab — DRUG
    Administered per the protocol
  • Cyclophosphamide — DRUG
    Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
  • Doxorubicin — DRUG
    Administered per the protocol as part of CHOP chemotherapy
  • Vincristine — DRUG
    Administered per the protocol as part of CHOP, and CVP chemotherapy
  • Prednisone/prednisolone — DRUG
    Administered per the protocol as part of CVP chemotherapy
  • Bendamustine — DRUG
    Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Study Details

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.

Key Dates

Start date
Dec 12, 2023
Status verified
May 2026
Primary completion
Feb 7, 2028
Completion
Nov 3, 2029

Study Design

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

Arms

  • Experimental: Odronextamab
    Part 1 is a safety run-in. All participants will receive odronextamab. In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.
  • Active Comparator: Rituximab + Investigator's Choice Chemotherapy
    Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab [ Time Frame: Up to 35 days ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
UC Irvine HealthOrangeCalifornia92868-
Investigative Clinical Research of IndianaNoblesvilleIndiana46062-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
Hattiesburg ClinicHattiesburgMississippi39401-
Icahn School of Medicine at Mt SinaiNew YorkNew York10029-
Stony Brook University HospitalStony BrookNew York11794-
Clinical Research Alliance IncWestburyNew York11590-
University of North CarolinaChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28207-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Center for Oncology and Blood DisordersHoustonTexas77030-
HOPE Cancer Center of East TexasTylerTexas75701-
Huntsman Cancer Institute - Oncology DivisionSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22908-
Virginia Commonwealth UniversityRichmondVirginia23219-
Prohealth Care IncWaukeshaWisconsin53188-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZDavid Geffen School of Medicine at UCLA· Los Angeles, CAUC Irvine Health· Orange, CAInvestigative Clinical Research of Indiana· Noblesville, INBeth Israel Deaconess Medical Center· Boston, MAKarmanos Cancer Institute· Detroit, MI

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