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NCT06091865 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Regeneron Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
904
Enrollment target
20
Study locations

NCT06091865 is a Phase 3 study of Diffuse Large B Cell Lymphoma (DLBCL) that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 904 participants, above the 172-participant average among 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials with a reported enrollment target (426% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT06091865, a Phase 3 study of Diffuse Large B Cell Lymphoma (DLBCL), is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
904 participants
Enrollment target
20
Study locations

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

Diffuse Large B Cell Lymphoma (DLBCL)

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

FieldValue
Enrollment Target 904 participants
Start Date 2023-12-13
Est. Completion 2029-09-02
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

280 total trials

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What the Registry Record Tells You About NCT06091865

The ClinicalTrials.gov registry entry for NCT06091865 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 904 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 172-participant average among 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials with a reported enrollment target (426% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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.

NCT06091865 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Indiana, Michigan.

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).

What interventions are being tested in trial NCT06091865?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG), Odronextamab (DRUG).

Who is sponsoring clinical trial NCT06091865?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

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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