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

Part of paid clinical trials in Plantation, Florida.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06097364
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Follicular Lymphoma (FL)

Eligibility Criteria

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

Interventions

  • Odronextamab — DRUG
    Administered by intravenous (IV) infusion
  • Rituximab — DRUG
    Administered by IV infusion, or subcutaneous (SC)
  • Cyclophosphamide — DRUG
    Administered by IV infusion
  • Doxorubicin — DRUG
    Administered by IV infusion
  • Vincristine — DRUG
    Administered by IV infusion
  • Prednisone/Prenisolone — DRUG
    Administered orally (PO)

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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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) * The impact from the study drug on quality-of-life and ability to complete routine daily activities

Key Dates

Start date
Nov 14, 2023
Status verified
Sep 2025
Primary completion
Jul 29, 2029
Completion
Jul 29, 2029

Study Design

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

Arms

  • Experimental: Odronextamab + Chemotherapy
    Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
  • Active Comparator: Rituximab + Chemotherapy
    In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
  • Experimental: Odronextamab + Chemotherapy + Maintenance
    In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance.
  • Experimental: Odronextamab + Chemotherapy + No maintenance
    In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy [ Time Frame: Up to 35 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
Boca Raton Clinical Research (BRCR) GlobalPlantationFlorida33322-
Investigative Clinical Research of IndianaNoblesvilleIndiana46062-
Cancer Center of KansasWichitaKansas67214-
University of KentuckyLexingtonKentucky40536-
Henry Ford Health SystemDetroitMichigan48202-
Cancer and Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Center for Oncology and Blood DisordersHoustonTexas77030-
Community Cancer Trials of UtahOgdenUtah84405-
Prohealth Care IncWaukeshaWisconsin53188-

Find similar trials in Plantation, FL

By research site
Boca Raton Clinical Research (BRCR) Global· Plantation, FLInvestigative Clinical Research of Indiana· Noblesville, INCancer Center of Kansas· Wichita, KSUniversity of Kentucky· Lexington, KYHenry Ford Health System· Detroit, MICancer and Hematology Centers of Western Michigan· Grand Rapids, MI

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