Non Hodgkin Lymphoma Clinical Trial

A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma

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 in Part 2, as well as participants with lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"), in Part 1. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL.

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 your 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 your quality-of-life and ability to complete routine daily activities

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV

For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL who have not received R-CHOP or R-CVP.
For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow and hepatic function.

Key Exclusion Criteria:

Participants with central nervous system lymphoma or leptomeningeal lymphoma
Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
Recent major surgery and history or organ transplantation
A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

733

Study ID:

NCT06097364

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 26 Locations for this study

See Locations Near You

Investigative Clinical Research of Indiana
Noblesville Indiana, 46062, United States More Info
Ruemu Birhiray
Principal Investigator
University of Kentucky
Lexington Kentucky, 40536, United States More Info
Chaitanya Iragavarapu
Principal Investigator
Cancer and Hematology Centers of Western Michigan
Grand Rapids Michigan, 49503, United States More Info
Colin Hardin
Principal Investigator
Clinical Research Alliance, Inc.
Westbury New York, 11590, United States More Info
James D'Olimpio
Principal Investigator
Center for Oncology and Blood Disorders
Houston Texas, 77030, United States More Info
Luis Camacho
Principal Investigator
Community Cancer Trials of Utah
Ogden Utah, 84405, United States More Info
Carl Gray
Principal Investigator
ProHealth Care Inc
Waukesha Wisconsin, 53188, United States More Info
Timothy Wassenaar
Principal Investigator
University Hospital Ghent
Ghent East Flanders, 9000, Belgium More Info
Ciel De Vriendt
Principal Investigator
AZ Groeninge
Kortrijk West Flanders, 8500, Belgium More Info
Koenraad Van Eygen
Principal Investigator
Clinica Universidad de los Andes
Santiago , 76201, Chile More Info
Cristian Carvallo
Principal Investigator
Pratia Onkologia Katowice
Katowice Silesia, 40-51, Poland More Info
Sebastian Grosicki
Principal Investigator
Clinica Universidad de Navarra - Sede Pamplona
Pamplona Navarre, 31008, Spain More Info
Carlos Grande
Principal Investigator
Clinica Universidad de Navarra - Sede Madrid
Madrid , 28027, Spain More Info
Carlos Grande Garcia
Principal Investigator
Hospital Universitario Infanta Leonor
Madrid , 28031, Spain More Info
Jose-Angel Hernandez-Rivas
Principal Investigator
Hosptial Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Francisco Javier Lopez Jimenez
Principal Investigator
Hospital Universitario Quironsalud Madrid
Madrid , 28223, Spain More Info
Maria Aranzazu Alonso Alonso
Principal Investigator
Hospital Universitario de Salamanca
Salamanca , 37007, Spain More Info
Alejandro Martin Garcia-Sancho
Principal Investigator
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain More Info
Fatima de la Cruz Vicente
Principal Investigator
Hospital Universitari Mutua Terrassa
Terrassa , 08221, Spain More Info
Ana Muntanola Prat
Principal Investigator
Sakayra University Training and Research Hospital
Adapazari Sakarya, 54290, Turkey More Info
Tuba Hacibekiroglu
Principal Investigator
Gazi University
Ankara , 06100, Turkey More Info
Munci Yagci
Principal Investigator
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara , 06200, Turkey More Info
Fevzi Altuntas
Principal Investigator
Istanbul University
Istanbul , 34093, Turkey More Info
Mustafa Yenerel
Principal Investigator
VKV American Hospital
Istanbul , 34365, Turkey More Info
Ahmet Ferhanoglu
Principal Investigator
Erciyes University
Kayseri , 38030, Turkey More Info
Ali Unal
Principal Investigator
Tekirdag Namik Kemal University Hospital
Tekirdag , 59100, Turkey More Info
Burhan Turgut
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

733

Study ID:

NCT06097364

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.