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
216 patients around the world
Available in Brazil
Regeneron Pharmaceuticals
13Research sites
216Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
B-cell lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
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.
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]).
Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate hematologic and organ function.
Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol.
History of or current relevant CNS pathology, as described in the protocol.
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.
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.
Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol.
Allergy/hypersensitivity to study drug, or excipients.
Sites
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Pr. da Cruz Vermelha, 23 - Centro, Rio de Janeiro - RJ, 20230-130
Hospital Sírio-Libanês
Recruiting
Rua Dona Adma Jafet, 91 - Bela Vista, São Paulo - SP, 01308-050, Brazil
Beneficência Portuguesa de São Paulo
Recruiting
R. Maestro Cardim, 637 - Bela Vista, São Paulo - SP, 01323-001
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Av. República do Líbano, 611 - Ibirapuera, São Paulo - SP, 04501-000