What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as rituximab combined with chemotherapy, often result in side effects including neutropenia, infections, fatigue, nausea, and infusion-related reactions. Bispecific antibodies like odronextamab, which target CD20 and CD3, may also cause cytokine release syndrome, neurotoxicity, and other immune-related adverse effects. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies such as rituximab, obinutuzumab, and ofatumumab, all targeting CD20. Additionally, bispecific T-cell engagers like blinatumomab, which targets CD19 and CD3, have been approved for certain B-cell malignancies. These therapies are similar to odronextamab, which is being studied for its dual targeting of CD20 and CD3.

What other types of research exist?

Promising novel alternatives to Odronextamab for Non-Hodgkin's Lymphoma patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory NHL. 2) Bispecific antibodies like glofitamab and epcoritamab, which target CD20 and CD3 and have demonstrated encouraging results in clinical trials. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which targets CD79b and has been effective in combination with other therapies. These alternatives offer different mechanisms of action and have shown promise in improving outcomes for NHL patients.

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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

Must not have

Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Allergy/hypersensitivity to study drugs, as described in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug called odronextamab with chemotherapy for patients with a type of lymphoma that hasn't been treated before, has come back, or hasn't responded to treatment. The study will check if this combination is safe and effective compared to the current standard treatment. Researchers will also look at side effects, how the drug behaves in the body, and its impact on daily life.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active infections, including COVID-19, HIV, hepatitis B or C, or CMV.

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I am not allergic to the drugs used in this study.

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I do not have severe nerve damage.

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I have a lymphoma affecting my brain or spinal cord.

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I am currently receiving or have received systemic therapy for lymphoma.

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I have had major surgery, an organ transplant, or standard radiotherapy recently.

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)

Incidence of treatment emergent adverse events (TEAEs)

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

Secondary study objectives

BOR assessed by ICR

Best Overall response (BOR) as assessed by local investigators

CR as assessed by local investigators

+22 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

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 (Odro-CHOP) dose optimization (Part 1B).

Group II: Rituximab + CHOPActive Control5 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Vincristine

2003

Completed Phase 4

~2970

Doxorubicin

2012

Completed Phase 3

~8030

Prednisone/Prednisolone

2017

Completed Phase 3

~2510

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies like rituximab and bispecific antibodies like odronextamab, often combined with chemotherapy. Rituximab targets the CD20 antigen on B-cells, leading to their destruction by the immune system. Odronextamab, a bispecific antibody, simultaneously binds to CD20 on B-cells and CD3 on T-cells, bringing them into close proximity to enhance the T-cells' ability to kill the B-cells. Chemotherapy works by targeting rapidly dividing cells, including cancer cells, to inhibit their growth and induce cell death. These mechanisms are vital for NHL patients as they provide multiple strategies to target and eliminate cancer cells, potentially improving treatment efficacy and patient outcomes.