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Recruiting Phase 3 NCT06230224

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Phase 3 – large-scale trial before approval
Conditions: B-Cell Non-Hodgkin Lymphoma (B-NHL)

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 patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug versus Standard of Care (SOC) * 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) * Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities
Who can participate
Key Inclusion Criteria: 1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 2. Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment 3. Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) 4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6. Adequate hematologic and organ function. Key Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol 2. History of or current relevant CNS pathology, as described in the protocol 3. A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated 4. 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 5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol 6. Allergy/hypersensitivity to study drug, or excipients. NOTE: Other protocol defined inclusion / exclusion criteria apply
Locations 16
Argentina (1)
Hospital Aleman
Ciudad Autonoma de Buenos Aires , Buenos Aires
Australia (1)
Liverpool Hospital
Liverpool , New South Wales
WITHDRAWN
Brazil (1)
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
Salvador , Estado de Bahia
Chile (1)
Fundacion Arturo Lopez Perez
Santiago , Santiago Metropolitan
Colombia (1)
Hospital Pablo Tobon Uribe
Medellín , Antioquia
Hungary (1)
University of Pecs
Pécs , Baranya
Italy (1)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , Forli-Cesena
WITHDRAWN
Malaysia (1)
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru , Johor
Netherlands (1)
Erasmus University Medical Center
Rotterdam
WITHDRAWN
Romania (1)
Coltea Clinical Hospital
Bucharest , Bucharest
Singapore (1)
National University Hospital Singapore
Singapore
South Korea (1)
National Cancer Center
Gyeonggi-do , Gyeonggi-do
Spain (1)
Hospital Universitario Virgen del Rocio
Seville , Andalusia
WITHDRAWN
Taiwan (1)
Chang Gung Medical Foundation
Chiayi City , Chianan Plain
WITHDRAWN
Thailand (1)
Chulalongkorn University
Bangkok
Turkey (1)
Ankara University Faculty of Medicine
Mamak , Ankara
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.02.2024
Completion date
14.05.2027
Registry ID
NCT06230224
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.