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Odronextamab+Lenalidomide for Marginal Zone Lymphoma (OLYMPIA-5 Trial)

Q: Has the combination of Odronextamab and Lenalidomide been given regulatory clearance by the FDA?

<p>The safety of the Odronextamab+<a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> combination has been evaluated to be a 3 due to prior clinical data that supports its efficacy and multiple findings supporting its security.</p>

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

Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator.

Must have refractory disease or relapsed after at least 2 cycles of prior systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-cluster of differentiation 20 (CD20) monoclonal antibody and patient should meet indication for treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

OLYMPIA-5 Trial Summary

This trial is studying an experimental drug to see if it is safe and effective in treating NHL with FL and MZL that has come back or not responded to treatment. It will compare the drug to current standard-of-care treatment.

Who is the study for?

This trial is for people with follicular lymphoma or marginal zone lymphoma that hasn't improved or has returned after treatment. Participants must have tried at least one anti-CD20 monoclonal antibody therapy and need more treatment. They should be able to perform daily activities (ECOG 0-2) and have measurable disease via CT or MRI scans.Check my eligibility

What is being tested?

The study tests odronextamab combined with lenalidomide against the standard rituximab plus lenalidomide in patients with certain types of Non-Hodgkin's lymphoma. Part 1 determines the safe dose; Part 2 compares effectiveness and safety between the two drug combinations.See study design

What are the potential side effects?

Potential side effects include reactions to odronextamab, such as immune system responses, infusion-related symptoms, impact on blood counts, organ function issues, and possibly developing antibodies against the study drug which could reduce its effectiveness.

OLYMPIA-5 Trial Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is confirmed to be of a specific type and grade.

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My cancer did not respond or came back after 2 treatments including an anti-CD20 drug.

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

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It seems like the criterion provided is incomplete. Can you please provide more context or details so I can assist you accurately?

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

OLYMPIA-5 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

Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with lenalidomide

Incidence of treatment emergent adverse events (TEAEs) for odronextamab in combination with lenalidomide

Progression-free survival (PFS) as assessed by independent central review (ICR) in participants with R/R FL and participants with indolent lymphoma

+1 more

Secondary outcome measures

BOR as assessed by ICR

Best overall response (BOR) as assessed by investigator review

Complete response (CR) as assessed by ICR

+19 more

OLYMPIA-5 Trial Design

2Treatment groups

Experimental Treatment

Group I: Rituximab+LenalidomideExperimental Treatment2 Interventions

In part 2 only, 1:1 randomized participants with R/R lymphoma (FL and ML), will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy.

Group II: Odronextamab+LenalidomideExperimental Treatment2 Interventions

In part 1 (safety run-in), participants with R/R indolent lymphoma (FL and ML), will receive odronextamab in combination with lenalidomide. In part 2, 1:1 randomized participants with indolent lymphoma (FL/MZL), will receive odronextamab in combination with lenalidomide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

Rituximab

1999

Completed Phase 4

~1880

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

621 Previous Clinical Trials

380,135 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

250,944 Total Patients Enrolled

Frequently Asked Questions

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

Are there any remaining spots open for participation in this research?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, which was posted on December 18th 2023, is actively seeking volunteers to participate in the study. About 470 patients need to be recruited from two distinct medical sites."

Answered by AI

How many people are taking part in this research endeavor?

"Yes, the information posted on clinicaltrials.gov confirms that this medical study is still enrolling patients; it was initially published on December 18th 2023 and has been revised as recently as December 14th of the same year. 470 subjects are required from two distinct sites for completion of the trial."

Answered by AI

Has the combination of Odronextamab and Lenalidomide been given regulatory clearance by the FDA?

"The safety of the Odronextamab+Lenalidomide combination has been evaluated to be a 3 due to prior clinical data that supports its efficacy and multiple findings supporting its security."

Answered by AI

Could you elucidate what aims this investigation is striving to achieve?

"Reported by Regeneron Pharmaceuticals, the principal endpoint measured over a two-year period is the incidence of adverse reactions in patients receiving odronextamab and lenalidomide. Additionally, this study will monitor CR as evaluated by ICR (Parts 1 & 2), BOR assessed through investigator analysis (Parts 1 & 2) and overall survival during Part 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma

2023. "A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06149286.

All > Marginal Zone Lymphoma > Follicular Lymphoma