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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

OLYMPIA-1 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.Check my eligibility

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.See study design

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.

OLYMPIA-1 Trial 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.

OLYMPIA-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

CR30 as assessed by local investigator

Change in score of the GP5 item in the participant population

Concentrations of odronextamab in serum

+28 more

OLYMPIA-1 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

622 Previous Clinical Trials

380,253 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

250,936 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Odronextamab a risk-free drug for humans?

"Odronextamab's safety is highly regarded, receiving a grade of 3 on our team's scale. This assessment was made possible due to the presence of relevant efficacy data and several rounds of research confirming its security profile."

Answered by AI

Are there any opportunities to join this experiment presently?

"Confirmative. According to clinicaltrials.gov, enrollment is still ongoing for this medical trial; the study was first posted on October 13th 2023 and has not been updated since then. 478 patients need to be enlisted from a single centre."

Answered by AI

What is the intended aim of this experiment?

"The main outcome to be assessed during this trial, which will span a maximum of 35 days, is the occurrence of adverse events related to odronextamab. Secondary endpoints include the incidence rate and titer level of anti-odronextamab antibodies as well as any neutralizing antibodies observed in response to treatment with odronextamab."

Answered by AI

How many individuals have been included in the scope of this research endeavor?

"Indeed, according to clinicaltrials.gov the trial is actively recruiting patients with a launch date of October 13th 2023 and most recent update on the same day. 478 total individuals are needed for this study which is taking place at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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 Participants With Follicular Lymphoma

2023. "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 Participants With Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091254.

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