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A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
NCT06091254 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Vincristine
- DRUG Odronextamab
Study Locations (20)
New York
- Icahn School of Medicine at Mt Sinai — New York
- Stony Brook University Hospital — Stony Brook
- Clinical Research Alliance Inc — Westbury
California
- David Geffen School of Medicine at UCLA — Los Angeles
- UC Irvine Health — Orange
North Carolina
- University of North Carolina — Chapel Hill
- Levine Cancer Institute — Charlotte
Texas
- Center for Oncology and Blood Disorders — Houston
- HOPE Cancer Center of East Texas — Tyler
Virginia
- University of Virginia — Charlottesville
- Virginia Commonwealth University — Richmond
Arizona
- University of Arizona Cancer Center — Tucson
Indiana
- Investigative Clinical Research of Indiana — Noblesville
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 822 participants |
| Start Date | 2023-12-12 |
| Est. Completion | 2029-11-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06091254
The ClinicalTrials.gov registry entry for NCT06091254 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 822 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Follicular Lymphoma (FL) appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06091254 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06091254 about?
NCT06091254 is a clinical study titled "A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma". This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (ran...
What is the current status of trial NCT06091254?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 822 participants. The study started on 2023-12-12. Estimated completion is 2029-11-03.
What conditions does trial NCT06091254 study?
This clinical trial studies the following conditions: Follicular Lymphoma (FL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06091254?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG), Odronextamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06091254?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06091254 being conducted?
This trial has 20 study locations across Arizona, California, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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