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 (NCT06091254) — UK Trial Details

Condition(s) studied

Follicular Lymphoma (FL)

Investigational drug(s) / intervention(s)

OdronextamabRituximabCyclophosphamideDoxorubicinVincristinePrednisone/prednisoloneBendamustine

Odronextamab: Administered per the protocol

Rituximab: Administered per the protocol

Cyclophosphamide: Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

Doxorubicin: Administered per the protocol as part of CHOP chemotherapy

Vincristine: Administered per the protocol as part of CHOP, and CVP chemotherapy

Prednisone/prednisolone: Administered per the protocol as part of CVP chemotherapy

Bendamustine: Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Key Inclusion Criteria: 1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV 2. Need for treatment as described in the protocol 3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Adequate bone marrow function and hepatic function, as described in the protocol Key Exclusion Criteria: 1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma 2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma 3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma 4. Treatment with any systemic anti-lymphoma therapy 5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab — Up to 35 days
Part 1
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab — Up to 2 years
Part 1
Severity of TEAEs of odronextamab — Up to 2 years
Part 1
Complete Response at 30 months (CR30) as assessed by independent central review — Up to 30 months
Part 2

Trial sites (190)

Facility	City	Region	Status
University of Arizona Cancer Center	Tucson	Arizona	Recruiting
David Geffen School of Medicine at UCLA	Los Angeles	California	Recruiting
UC Irvine Health	Orange	California	Withdrawn
Investigative Clinical Research of Indiana	Noblesville	Indiana	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Hattiesburg Clinic	Hattiesburg	Mississippi	Completed
Icahn School of Medicine at Mt Sinai	New York	New York	Recruiting
Stony Brook University Hospital	Stony Brook	New York	Recruiting
Clinical Research Alliance Inc	Westbury	New York	Withdrawn
University of North Carolina	Chapel Hill	North Carolina	Recruiting
Levine Cancer Institute	Charlotte	North Carolina	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
Center for Oncology and Blood Disorders	Houston	Texas	Recruiting
HOPE Cancer Center of East Texas	Tyler	Texas	Withdrawn
Huntsman Cancer Institute - Oncology Division	Salt Lake City	Utah	Recruiting
University of Virginia	Charlottesville	Virginia	Recruiting
Virginia Commonwealth University	Richmond	Virginia	Withdrawn
Prohealth Care Inc	Waukesha	Wisconsin	Withdrawn
Ingham Institute	Liverpool	New South Wales	Recruiting
Icon Cancer Centre - Wesley	Auchenflower	Queensland	Completed
Flinders Medical Centre	Bedford Park	South Australia	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Epworth Freemasons	East Melbourne	Victoria	Recruiting
Alfred Hospital and Monash University	Melbourne	Victoria	Recruiting
St Vincents Hospital Melbourne	Melbourne	Victoria	Recruiting
Ordensklinikum Linz	Linz	Osterreich	Recruiting
Ordensklinikum Linz Gmbh, Elisabethinen	Linz	Austria	Recruiting
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III	Salzburg	Austria	Recruiting
Medical University of Vienna	Vienna	Austria	Recruiting
Hanusch Krankenhaus	Vienna	Austria	Recruiting
AZ St.-Elisabeth Herentals vzw	Herentals	Antwerp	Withdrawn
Hopital De Jolimont	La Louvière	Hainaut	Withdrawn
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital	Ghent	Oost-Vlaanderen	Withdrawn
Ziekenhuis Netwerk Antwerpen Stuivenberg	Antwerp	Belgium	Withdrawn
Institut Jules Bordet	Brussels	Belgium	Withdrawn
Ensino e Terapia de Inovacao Clinica Amo (Etica)	Salvador	Estado de Bahia	Recruiting
Instituto Mario Pena de Ensino Pesquisa e Inovacao	Belo Horizonte	Minas Gerais	Recruiting
Liga Norte Riograndense Contra o Cancer	Natal	Rio Grande do Norte	Recruiting

+ 150 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

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