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Anti-tumor antibiotic

Odronextamab + Chemotherapy for Follicular Lymphoma (OLYMPIA-2 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 diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV

For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

OLYMPIA-2 Trial Summary

This trial researches an experimental drug to treat a type of non-Hodgkin lymphoma to assess safety, effectiveness, and side effects.

Who is the study for?

Adults with previously untreated follicular lymphoma can join this trial. They should be able to perform daily activities (ECOG 0-2) and have a certain level of disease severity (FLIPI-1 score). Participants must not have other types of lymphomas, recent major surgeries, organ transplants, or any condition that could risk their safety in the study.Check my eligibility

What is being tested?

The trial is testing odronextamab combined with chemotherapy against the standard rituximab with chemotherapy. It's divided into three parts: initial non-randomized phases to determine safe dosages and a final phase comparing effectiveness between treatments.See study design

What are the potential side effects?

Potential side effects include reactions to odronextamab such as immune responses against the drug, infusion-related symptoms, impact on blood levels and organ function. The study also monitors quality-of-life changes due to treatment.

OLYMPIA-2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My lymphoma is CD20 positive and is either stage II bulky or stage III/IV.

Select...

My FLIPI score for lymphoma is between 0 and 5, and I haven't been treated yet.

Select...

I am able to get out of my bed or chair and move around.

Select...

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

OLYMPIA-2 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 rate at 30 months (CR30) assessed by independent central review (ICR)

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

Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy

+1 more

Secondary outcome measures

BOR as assessed by ICR

BOR as assessed by local investigator

Best overall response (BOR) as assessed by the investigator

+27 more

OLYMPIA-2 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Odronextamab + Chemotherapy + No maintenanceExperimental Treatment2 Interventions

In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.

Group II: Odronextamab + Chemotherapy + MaintenanceExperimental Treatment2 Interventions

In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy [CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)], followed by odronextamab monotherapy maintenance.

Group III: Odronextamab + ChemotherapyExperimental Treatment4 Interventions

Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (O) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.

Group IV: Rituximab + ChemotherapyActive Control6 Interventions

In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Doxorubicin

2012

Completed Phase 3

~7940

Vincristine

2003

Completed Phase 4

~2910

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

621 Previous Clinical Trials

379,872 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

250,681 Total Patients Enrolled

Frequently Asked Questions

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

To what extent can Odronextamab + Chemotherapy prove detrimental to patients?

"Odronextamab + Chemotherapy garnered a score of 3 on the safety scale due to the existence of supporting data from Phase 3 trials for efficacy and repeated evidence confirming its safety."

Answered by AI

Are recruitment efforts still underway for participants in this trial?

"According to clinicaltrials.gov, this medical investigation is currently seeking test subjects; the trial was initially advertised on November 8th 2023 and recently modified on October 18th 2023."

Answered by AI

How extensive is the recruitment process for this experiment?

"Affirmative. According to data on clinicaltrials.gov, this investigation is currently enrolling patients and was initially announced on November 8th 2023 with the last edit being made October 18th 2023. 733 people are needed from 1 site for participation in this trial."

Answered by AI

What does the research team hope to gain from this experiment?

"This clinical trial, running for a maximum of 35 days, seeks to determine the safety of odronextamab when used in combination with chemotherapy. Secondary objectives include measuring serum concentrations and anti-odronextamab antibodies created during Part 1 and Part 2 as well as titers of these antibodies over two stages."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma

2023. "A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097364.

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