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Anti-metabolites

Odronextamab vs Chemotherapy for Follicular Lymphoma (OLYMPIA-1 Trial)

Phase 3

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed tomography (CT) or Magnetic resonance imaging (MRI)

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

Must not have

Central nervous system (CNS) lymphoma or leptomeningeal lymphoma

Treatment with any systemic anti-lymphoma therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is looking into an experimental drug to treat follicular lymphoma (type of NHL). It will look at the drug's safety & effectiveness compared to current standard of care. It will also look at side effects & impact on quality of life.

Who is the study for?

This trial is for adults with a type of non-Hodgkin lymphoma called follicular lymphoma, who haven't been treated before. They should have a certain level of physical fitness (ECOG 0-2) and their bone marrow and liver must be functioning well. People with CNS involvement, transformed high-grade lymphomas, or specific other conditions are excluded.

What is being tested?

The study tests odronextamab against the usual treatment combination of rituximab and chemotherapy for follicular lymphoma. It has two parts: first to check safety and tolerability, then to compare effectiveness. The study also looks at how much drug is in the blood over time, potential antibodies against it, side effects, and life quality impacts.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to odronextamab which could affect various organs; infusion-related reactions; possible development of antibodies that might reduce drug effectiveness or cause additional side effects; impact on daily activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured on a CT or MRI scan.

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My condition is CD20+ follicular lymphoma, grade 1-3a, at an advanced stage.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is in the brain or spinal cord.

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I am currently receiving or have received systemic therapy for lymphoma.

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My lymphoma has changed into a more aggressive form.

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I have been diagnosed with a specific type of blood cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Incidence of dose-limiting toxicities (DLTs) for odronextamab

Incidence of treatment-emergent adverse events (TEAEs) of odronextamab

+1 more

Secondary study objectives

CR30 as assessed by local investigator

Change in score of the GP5 item in the participant population

Concentrations of odronextamab in serum

+27 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OdronextamabExperimental Treatment1 Intervention

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.

Group II: Rituximab + Investigator's Choice ChemotherapyActive Control6 Interventions

Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.

0 / 7Eligibility criteria met