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Odronextamab + Lenalidomide for Lymphoma (OLYMPIA-5 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

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

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

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.

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

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 study objectives

BOR as assessed by ICR

Best overall response (BOR) as assessed by investigator review

Complete response (CR) as assessed by ICR

+19 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

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 MZL), 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

Rituximab

1999

Completed Phase 4

~2990

Lenalidomide

2005

Completed Phase 3

~2240