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NCT06091254 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Follicular Lymphoma (FL), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 822
- Enrollment target
- 20
- Study locations
NCT06091254 is a Phase 3 study of Follicular Lymphoma (FL) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 822 participants, above the 450-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (83% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT06091254, a Phase 3 study of Follicular Lymphoma (FL), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 822 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 822 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 450-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (83% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
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.
NCT06091254 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, North Carolina.
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).
What interventions are being tested in trial NCT06091254?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG), Odronextamab (DRUG).
Who is sponsoring clinical trial NCT06091254?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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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Related
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