Health Trials

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

ConditionFollicular Lymphoma (FL)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV

Need for treatment as described in the protocol

Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Disqualifiers

Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma

Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma

Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma

Treatment with any systemic anti-lymphoma therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

822 Participants
are divided into 2 treatment groups
Group A: OdronextamabExperimental treatment 1 intervention
Group B: Rituximab + Investigator's Choice ChemotherapyActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab

Part 1

Time frame
Up to 35 days
2

Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab

Part 1

Time frame
Up to 2 years
3

Severity of TEAEs of odronextamab

Part 1

Time frame
Up to 2 years
4

Complete Response at 30 months (CR30) as assessed by independent central review

Part 2

Time frame
Up to 30 months

Secondary outcomes

1

Concentrations of odronextamab in serum

Part 1

Time frame
Up to 30 months
2

Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab

Part 1

Time frame
Up to 30 months
3

Magnitude of ADAs to odronextamab

Part 1

Time frame
Up to 30 months
4

Objective response as assessed by the investigator

Part 1

Time frame
Up to 30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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