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About
The 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 effective the study drug is compared to standard of care (SOC) therapy.
The study is looking at several other research questions, including:
Enrollment
Sex
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Volunteers
Inclusion criteria
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.
Treatment at frontline should have included anti-cluster of differentiation 20 (anti-CD20) antibody and anthracycline-containing regimen.
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).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate hematologic and organ function.
Exclusion criteria
NOTE: Other protocol defined inclusion / exclusion criteria apply
Primary purpose
Allocation
Interventional model
Masking
216 participants in 2 patient groups
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Central trial contact
Clinical Trials Administrator
Data sourced from clinicaltrials.gov
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