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Odronextamab for B-Cell Lymphoma (ELM-2 Trial)
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.
ELM-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELM-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ELM-2 Trial Design
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Who is running the clinical trial?
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- My liver, kidneys, and bone marrow are functioning well.I haven't taken more than 10 mg of steroids daily in the last 3 days.I have been treated with a therapy targeting both CD20 and CD3.My doctor thinks I need treatment for my lymphoma now.I haven't taken any lymphoma medication recently.My disease can be seen and measured on a CT or MRI scan.I am fully active or restricted in physically strenuous activity but can do light work.I do not have uncontrolled HIV, hepatitis B or C, or CMV infections.I have not had cancer, except for certain skin cancers or cervical cancer, in the last 5 years.My B-NHL has not responded to at least 2 treatments and is not Burkitt lymphoma.My MZL has not responded to at least 2 previous treatments.I have previously received CAR-T cell therapy.I have had a stem cell transplant from a donor.My condition did not improve after two different treatments.You are allergic to both allopurinol and rasburicase.My lymphoma is confirmed as grade 1-3a, not 3b, by a central review.My lymphoma affects or is suspected to affect my brain or spinal cord.I have not had a seizure or been diagnosed with a brain disorder in the last year.My DLBCL has not responded to at least 2 previous treatments.
- Group 1: Other B-NHL
- Group 2: FL
- Group 3: MCL
- Group 4: MZL
- Group 5: DLBCL
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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