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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: Recruiting Phase 3 study of Follicular Lymphoma (FL), sponsored by Regeneron Pharmaceuticals.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Part 1

Conditions Studied

Follicular Lymphoma (FL)

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

FieldValue
Enrollment Target 822 participants
Start Date 2023-12-12
Est. Completion 2029-11-03
Phase Phase 3
Regeneron Pharmaceuticals

280 total trials

What NCT06091254 shows while recruiting

NCT06091254 is an interventional study that assigns participants to a tested intervention. The registered 822 participants enrollment target is mid-sized for trials with a published cap, above the 450-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (83% higher).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Follicular Lymphoma (FL)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06091254's enrollment target sits among peer trials

822 2nd of 10 the highest of 10 other Follicular Lymphoma (FL) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Follicular Lymphoma (FL) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06091254

Source: ClinicalTrials.gov NCT06091254, the US trial registry maintained by the National Library of Medicine. NCT06091254 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.