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A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
NCT06091865 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 when combined with chemotherapy * 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) * The impact from the study drug on 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)
California
- David Geffen School of Medicine at UCLA — Los Angeles
- University of California Irvine Medical Center — Orange
- University of California (UC) Davis — Sacramento
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
- St Vincent Ascension at Peyton Manning Childrens Hospital — Indianapolis
- Investigative Clinical Research of Indiana — Noblesville
Michigan
- Henry Ford Health System — Detroit
- Cancer and Hematology Centers of Western Michigan — Grand Rapids
New York
- Stony Brook University Hospital — Stony Brook
- Clinical Research Alliance Inc — Westbury
New South Wales
- Liverpool Hospital — Liverpool
- Calvary Mater Newcastle — Waratah
Kentucky
- University of Kentucky — Lexington
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 904 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2029-09-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06091865
The ClinicalTrials.gov registry entry for NCT06091865 describes a study currently listed as active not 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 904 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 Diffuse Large B-cell Lymphoma (DLBCL) 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: NCT06091865 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Indiana, Michigan. 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 NCT06091865 about?
NCT06091865 is a clinical study titled "A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma". This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBC...
What is the current status of trial NCT06091865?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 904 participants. The study started on 2023-12-13. Estimated completion is 2029-09-02.
What conditions does trial NCT06091865 study?
This clinical trial studies the following conditions: Diffuse Large B-cell Lymphoma (DLBCL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06091865?
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 NCT06091865?
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 NCT06091865 being conducted?
This trial has 20 study locations across California, Indiana, Kentucky, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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