OU Health | Stephenson Cancer Center
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About
This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).
The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.
The study is looking at several other research questions, including:
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
Disease-specific cohorts:
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment.
Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow, hepatic, and renal function as defined in the protocol
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Primary purpose
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Interventional model
Masking
576 participants in 5 patient groups
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Clinical Trials Administrator
Data sourced from clinicaltrials.gov
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