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Alkylating agents

Odronextamab + Chemotherapy for B-Cell Lymphoma (OLYMPIA-3 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

Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol

International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

OLYMPIA-3 Trial Summary

This trial is testing an experimental drug (odronextamab) with chemotherapy to treat diffuse large B-cell lymphoma (DLBCL) in patients previously untreated, relapsed, or refractory. It will compare the effectiveness to the current standard of care to see how safe and tolerable it is.

Who is the study for?

This trial is for adults with a life expectancy of at least 12 months who have either not been treated for diffuse large B-cell lymphoma (DLBCL), or whose DLBCL has relapsed or not responded to treatment. They should have measurable disease, be reasonably fit (ECOG ≤2), and their organs must function well. People with another active cancer, severe medical conditions, recent major surgery, organ transplants, certain infections like COVID-19 or hepatitis, CNS involvement by lymphoma, prior anti-lymphoma therapy or allergies to study drugs cannot join.Check my eligibility

What is being tested?

The trial compares the effectiveness and safety of an experimental drug called odronextamab combined with chemotherapy versus rituximab combined with chemotherapy in patients with previously untreated DLBCL. It's divided into parts: early phases determine the best dose and schedule of odronextamab; later phase tests its efficacy against standard care rituximab.See study design

What are the potential side effects?

Potential side effects from taking odronextamab may include reactions related to infusion of the drug into your body, possible development of antibodies against the drug which could reduce its effectiveness or cause other side effects, impact on quality of life and daily activities.

OLYMPIA-3 Trial Eligibility Criteria

Inclusion Criteria

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

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I have at least one measurable cancer lesion.

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My DLBCL is considered high-risk based on the IPI score.

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I can take care of myself but might not be able to do heavy physical work.

OLYMPIA-3 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)

Incidence of treatment emergent adverse events (TEAEs)

Progression free survival (PFS), assessed by independent central review (ICR)

Secondary outcome measures

BOR assessed by ICR

Best Overall response (BOR) as assessed by local investigators

CR as assessed by local investigators

+22 more

OLYMPIA-3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Odronextamab + CHOPExperimental Treatment5 Interventions

Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (O-CHOP) dose optimization, (Part 1B).

Group II: Rituximab + CHOPActive Control5 Interventions

Part 2 is the randomized controlled portion, participants will receive either O-CHOP or R-CHOP.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Vincristine

2003

Completed Phase 4

~2910

Doxorubicin

2012

Completed Phase 3

~7940

Prednisone/Prednisolone

2014

Completed Phase 3

~1410

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

621 Previous Clinical Trials

379,701 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

250,510 Total Patients Enrolled

Frequently Asked Questions

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

What is the regulatory status of Odronextamab + CHOP?

"Our team at Power rated the safety of Odronextamab + CHOP a 3 due to existing clinical data that confirms its efficacy and numerous rounds of testing that have proven its security."

Answered by AI

How many volunteers are currently enlisted in this research experiment?

"Affirmative. Clinicaltrials.gov documents demonstrate that this medical trial, first posted on October 18th 2023, is actively recruiting participants at the moment. The research team requires a total of 904 individuals from one facility to participate in their experiment."

Answered by AI

Are there any vacancies available for individuals to partake in this experiment?

"Yes, based on the clinicaltrials.gov page, this research is recruiting participants at present. The trial was first announced on October 18th 2023 and has been revised as of October 13th 2023. This study needs to enroll 904 individuals from a single site."

Answered by AI

What impact are researchers hoping to achieve through this clinical experiment?

"This experiment, which will be gauged over a span of up to 35 days, aims to measure the occurrence of adverse reactions due to treatment. Secondary goals include full remission measured by ICR (Part 2), overall survival rate (Part 2), and best overall response assessed by local investigators (Parts 1 & 2)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

2023. "A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091865.

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