What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma that target CD20 on B-cells, such as rituximab and similar monoclonal antibodies, often cause infusion reactions, particularly during the first cycle. These reactions can include fever, chills, nausea, headache, and hypotension. Other side effects may involve infections due to immunosuppression, cytopenias (e.g., neutropenia, thrombocytopenia), cardiovascular events like hypertension and atrial fibrillation, fatigue, gastrointestinal disturbances, and general infusion-related reactions.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL) target CD20 on B-cells, similar to Odronextamab. Rituximab, an anti-CD20 monoclonal antibody, was one of the first and has been widely used in combination with chemotherapy. Other anti-CD20 antibodies include Obinutuzumab and Ofatumumab, which have shown efficacy in various subtypes of NHL. These treatments work by binding to the CD20 protein on the surface of B-cells, leading to cell death and reduced tumor burden. The development of these drugs has significantly improved outcomes for patients with NHL.

What other types of research exist?

Promising novel alternatives to Odronextamab for Non-Hodgkin's Lymphoma patients include: <ol> <li>Ibrutinib: A BTK inhibitor used as a single agent or in combination with other therapies, showing efficacy in various B-cell malignancies.</li> <li>Acalabrutinib: Another BTK inhibitor with a different toxicity profile, often used in patients who may not tolerate Ibrutinib.</li> <li>Venetoclax: A BCL-2 inhibitor, particularly effective in combination with obinutuzumab for CLL and showing promise in other B-cell lymphomas.</li> <li>CAR T-cell therapies: Such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory B-cell lymphomas.</li> <li>Bispecific T-cell Engagers (BiTEs): Such as blinatumomab, which targets CD19 on B-cells and has shown efficacy in B-cell malignancies.</li> </ol>

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Monoclonal Antibodies

Odronextamab for B-Cell Lymphoma (ELM-2 Trial)

Phase 2

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 on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Must not have

Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug

Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 194 weeks following the first dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing odronextamab, a medication that helps the immune system fight cancer, on patients with certain types of B-cell non-Hodgkin lymphoma who have not responded to previous treatments. The drug works by guiding the immune system to attack cancer cells. Odronextamab is being tested for its safety and effectiveness in patients with these types of cancer.

Who is the study for?

This trial is for patients with B-cell Non-Hodgkin Lymphoma who have already tried at least two other treatments, including an anti-CD20 antibody and an alkylating agent. They should be in good physical condition (ECOG status 0 or 1) and have proper organ function. People with certain types of lymphomas, uncontrolled infections like HIV or hepatitis, recent seizures, a history of neurodegenerative conditions, or those treated with CAR-T therapy are not eligible.

What is being tested?

The trial is testing Odronextamab's ability to fight cancer in different subtypes of B-cell Non-Hodgkin Lymphoma by measuring the response rate to treatment. It will also look at how long patients live without their disease getting worse, overall survival time, duration of response to treatment, control over the disease progression and its safety profile.

What are the potential side effects?

While specific side effects for Odronextamab aren't listed here, similar cancer treatments often cause fatigue, infusion reactions (like fever or chills), increased risk of infection due to weakened immune system responses and potential liver issues.

Eligibility Criteria

Inclusion Criteria

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

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My disease can be seen and measured on a CT or MRI scan.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My B-NHL has not responded to at least 2 treatments and is not Burkitt lymphoma.

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My MZL has not responded to at least 2 previous treatments.

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My condition did not improve after two different treatments.

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My DLBCL has not responded to at least 2 previous treatments.

Exclusion Criteria

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

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I haven't taken more than 10 mg of steroids daily in the last 3 days.

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I have been treated with a therapy targeting both CD20 and CD3.

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I haven't taken any lymphoma medication recently.

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I do not have uncontrolled HIV, hepatitis B or C, or CMV infections.

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I have previously received CAR-T cell therapy.

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I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 194 weeks following the first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 194 weeks following the first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 194 weeks following the first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ORR, as assessed by independent central review

Objective response rate (ORR), as assessed by independent central review

Secondary study objectives

CR rate, as assessed by independent central review

CR rate, as assessed by the local investigator

Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L)

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Other B-NHLExperimental Treatment1 Intervention

Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed

Group II: MZLExperimental Treatment1 Intervention

Marginal Zone Lymphoma cohort

Group III: MCLExperimental Treatment1 Intervention

Mantle Cell Lymphoma cohort

Group IV: FLExperimental Treatment1 Intervention

Follicular lymphoma grade 1-3a cohort

Group V: DLBCLExperimental Treatment1 Intervention

Diffuse large B-cell lymphoma cohort

0 / 12Eligibility 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

Common treatments for Non-Hodgkin's Lymphoma (NHL) often involve monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, which target the CD20 protein on B-cells. These antibodies work by binding to CD20, leading to direct cell death or marking the cancerous cells for immune system destruction. This targeted approach is significant for NHL patients as it aims to specifically eliminate malignant B-cells, potentially reducing side effects and improving treatment efficacy compared to non-specific therapies.