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NCT06149286 · ClinicalTrials.gov registry record · Phase 3
A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
A Phase 3 study of Relapsed/Refractory Follicular Lymphoma and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 470
- Enrollment target
- 20
- Study locations
NCT06149286: Recruiting Phase 3 study of Relapsed/Refractory Follicular Lymphoma and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL), sponsored by Regeneron Pharmaceuticals.
NCT06149286 is a Phase 3 study of Relapsed/Refractory Follicular Lymphoma and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 470 participants, below the 541-participant average among 3 other Relapsed/Refractory Follicular Lymphoma trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06149286, a Phase 3 study of Relapsed/Refractory Follicular Lymphoma and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 470 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide * 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
Primary Outcome
Part 1
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Odronextamab
Study Locations (20)
New York
- Stony Brook University Hospital - Stony Brook
- Clinical Research Alliance Inc - Westbury
New South Wales
- Liverpool Hospital - Liverpool
- Calvary Mater Newcastle - Waratah
Other
- Medical University Vienna - Vienna
- Klinikum Wels-Grieskirchen - Wels
California
- David Geffen School of Medicine at UCLA - Los Angeles
Florida
- Boca Raton Clinical Research (BRCR) Global - Plantation
Indiana
- Indiana University and Comprehensive Cancer Center - Indianapolis
Mississippi
- Hattiesburg Clinic - Hattiesburg
New Hampshire
- Dartmouth Cancer Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2023-12-28 |
| Est. Completion | 2029-01-23 |
| Phase | Phase 3 |
What NCT06149286 shows while recruiting
NCT06149286 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, below the 541-participant average among 3 other Relapsed/Refractory Follicular Lymphoma trials with a reported enrollment target (13% lower).
The record links to 2 conditions, with Relapsed/Refractory Follicular Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT06149286 names 20 study sites across 17 states, led by New York, New South Wales, Other.
Frequently Asked Questions
What is clinical trial NCT06149286 about?
NCT06149286 is a clinical study titled "A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma". This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (cal...
What is the current status of trial NCT06149286?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 470 participants. The study started on 2023-12-28. Estimated completion is 2029-01-23.
What conditions does trial NCT06149286 study?
This clinical trial studies the following conditions: Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL).
What interventions are being tested in trial NCT06149286?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Odronextamab (DRUG).
Who is sponsoring clinical trial NCT06149286?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06149286 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Mississippi, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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