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NCT06097364 · ClinicalTrials.gov registry record · Phase 3
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
A Phase 3 study of Follicular Lymphoma (FL), sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 733
- Enrollment target
- 20
- Study locations
NCT06097364 is a Phase 3 study of Follicular Lymphoma (FL) that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 733 participants, above the 459-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (60% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT06097364, a Phase 3 study of Follicular Lymphoma (FL), is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 733 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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). 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 to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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) * 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)
Michigan
- Henry Ford Health System - Detroit
- Cancer and Hematology Centers of Western Michigan - Grand Rapids
New South Wales
- Liverpool Hospital - Liverpool
- Calvary Mater Newcastle - Waratah
Styria
- Medical University of Graz - Graz
- Landeskrankenhaus Hochsteiermark - Leoben
Other
- Universitatsklinik fur Kinder und Jungendheilkunde - Vienna
- Klinikum Wels-Grieskirchen - Wels
Florida
- Boca Raton Clinical Research (BRCR) Global - Plantation
Indiana
- Investigative Clinical Research of Indiana - Noblesville
Kansas
- Cancer Center of Kansas - Wichita
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 733 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2029-07-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06097364
The ClinicalTrials.gov registry entry for NCT06097364 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 733 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 459-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (60% 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.
NCT06097364 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Michigan, New South Wales, Styria.
Frequently Asked Questions
What is clinical trial NCT06097364 about?
NCT06097364 is a clinical study titled "A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With 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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back af...
What is the current status of trial NCT06097364?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 733 participants. The study started on 2023-11-14. Estimated completion is 2029-07-29.
What conditions does trial NCT06097364 study?
This clinical trial studies the following conditions: Follicular Lymphoma (FL).
What interventions are being tested in trial NCT06097364?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG), Odronextamab (DRUG).
Who is sponsoring clinical trial NCT06097364?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06097364 being conducted?
This trial has 20 study locations across Florida, Indiana, Kansas, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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