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Набира участници Фаза 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

Фаза 3 – широко изпитване преди одобрение
Заболявания: B-Cell Non-Hodgkin Lymphoma (B-NHL)

Спонсор: Regeneron Pharmaceuticals

Налично на: БГ
Обобщение
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
Кой може да участва
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
Места на провеждане 16
Argentina (1)
Hospital Aleman
Ciudad Autonoma de Buenos Aires , Buenos Aires
Австралия (1)
Liverpool Hospital
Liverpool , New South Wales
WITHDRAWN
Бразилия (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
Унгария (1)
University of Pecs
Pécs , Baranya
Италия (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
Нидерландия (1)
Erasmus University Medical Center
Rotterdam
WITHDRAWN
Румъния (1)
Coltea Clinical Hospital
Bucharest , Bucharest
Сингапур (1)
National University Hospital Singapore
Singapore
Южна Корея (1)
National Cancer Center
Gyeonggi-do , Gyeonggi-do
Испания (1)
Hospital Universitario Virgen del Rocio
Seville , Andalusia
WITHDRAWN
Taiwan (1)
Chang Gung Medical Foundation
Chiayi City , Chianan Plain
WITHDRAWN
Тайланд (1)
Chulalongkorn University
Bangkok
Турция (1)
Ankara University Faculty of Medicine
Mamak , Ankara
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.02.2024
Крайна дата
14.05.2027
Регистрационен номер
NCT06230224
Източник
anzctr
Запитване за медицински туризъм

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