Language: BG BG
← Back to results
Recruiting Phase 3 NCT06091254

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

Phase 3 – large-scale trial before approval
Conditions: Follicular Lymphoma (FL)

Sponsor: Regeneron Pharmaceuticals

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 18
Australia (1)
Ingham Institute
Liverpool , New South Wales
Belgium (1)
AZ St.-Elisabeth Herentals vzw
Herentals , Antwerp
Brazil (1)
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador , Estado de Bahia
Canada (1)
Tom Baker Cancer Center
Calgary , Alberta
Chile (1)
Fundacion Arturo Lopez Perez
Santiago , Santiago Metropolitan
Czech Republic (1)
University Hospital Hradec Kralove
Hradec Králové
France (1)
Centre Hospitalier Universitaire (CHU) Rennes
Rennes , Brittany Region
Germany (1)
Robert-Bosch-Krankenhaus
Stuttgart , Baden-Wurttemberg
WITHDRAWN
Israel (1)
Samson Assuta Ashdod University Hospital
Ashdod
Italy (1)
Istituto Romagnolo Per Lo Studio Dei Tumori
Meldola , Forli Cesena
Poland (1)
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych , Lower Silesian Voivodeship
South Korea (1)
Center for Hematologic Malignancy
Goyang-si , Gyeonggi-do
WITHDRAWN
Spain (1)
University Hospital of Santiago de Compostela
Santiago de Compostela , A Coruna
Switzerland (1)
Kantonsspital Baden
Baden , Canton of Aargau
Taiwan (1)
Chang Gung Medical Foundation Chia Yi Branch
Buzi , Chiayi County
WITHDRAWN
Turkey (1)
Ankara University Faculty of Medicine
Mamak , Ankara
United Kingdom (1)
Royal Cornwall Hospitals NHS Trust
Truro , Cornwall
United States (1)
University of Arizona Cancer Center
Tucson , Arizona
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.12.2023
Completion date
03.11.2029
Registry ID
NCT06091254
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.