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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
Adequate bone marrow, hepatic, and renal function as defined in the protocol
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Awards & highlights

ELM-2 Trial Summary

This trial is testing a new antibody to treat several types of lymphoma that have relapsed or are resistant to other treatments. The primary goal is to see if the antibody shrinks tumors. Secondary goals are to see if the antibody prolongs progression-free survival, overall survival, and duration of response, and to assess the antibody's safety and tolerability.

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.Check my eligibility
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.See study design
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.

ELM-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver, kidneys, and bone marrow are functioning well.
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My doctor thinks I need treatment for my lymphoma now.
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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 lymphoma is confirmed as grade 1-3a, not 3b, by a central review.
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My DLBCL has not responded to at least 2 previous treatments.

ELM-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and first patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ORR (FL grade 1-3a/MZL)
Secondary outcome measures
CR rate (DLBCL/MCL/Other B-NHL)
CR rate (FL grade 1-3a/MZL)
Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30
+14 more

ELM-2 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

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
615 Previous Clinical Trials
379,335 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
259 Previous Clinical Trials
250,532 Total Patients Enrolled

Media Library

Odronextamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03888105 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Other B-NHL, FL, MCL, MZL, DLBCL
Non-Hodgkin's Lymphoma Clinical Trial 2023: Odronextamab Highlights & Side Effects. Trial Name: NCT03888105 — Phase 2
Odronextamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03888105 — Phase 2

Frequently Asked Questions

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

Has Odronextamab received regulatory approval from the FDA?

"While there is some data supporting the safety of Odronextamab, as this is only a Phase 2 trial, none of it supports efficacy. Therefore, we have given it a score of 2."

Answered by AI

Are there any patients currently being sought for this research?

"That is correct. The online clinicaltrials.gov database has the most recent information on this study, which shows that it is still actively recruiting patients. This particular trial was posted on November 13th 2019 and updated September 2nd 2022. In total, 35 sites are participating in this research project and 512 patients have been enrolled thus far."

Answered by AI

What other research exists on this topic?

"Research into odronextamab began in 2015 with a Phase 1 clinical trial conducted by Regeneron Pharmaceuticals. Since that first study, which enrolled 298 patients, the medication has undergone 3 additional trials across 15 countries and 46 cities."

Answered by AI

How many patients will be included in this clinical trial?

"According to the information available on clinicaltrials.gov, this clinical trial is still recruiting patients. The study was first posted on November 13th, 2019 and was updated as recently as September 2nd, 2020. They are looking for 512 participants at 35 different sites."

Answered by AI

How many total research facilities are coordinating this experiment?

"To avoid any unnecessary stress, it is best to select a trial site close to your location from the 35 different centres spread out across Edmonton, Saint Louis and Morristown."

Answered by AI

What other research studies have included Odronextamab?

"There are three ongoing studies that focus on Odronextamab. None of these active trials have reached Phase 3 yet. Most of the research for this treatment is based in Barcelona and California; however, there are 259 total locations running these clinical trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated
2019. "A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03888105.
~140 spots leftby Dec 2025
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