Brief Summary
This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin’s lymphomacancers of the lymphatic system (B-NHL).
The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs cellsthe basic structural and functional unit of all living things and to learn more about the safety of odronextamab.
The study is looking at several other research questions, including:
- To see if odronextamab works to destroy cancer cells
- Side effects that may be experienced by people taking odronextamab
- How odronextamab works in the body
- How much odronextamab is present in the bloodthe red bodily fluid that transports oxygen and other nutrients around the body
Intervention / Treatment
- Drug: Odronextamab
Inclusion Criteria
- For the FL gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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.
- FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton’s tyrosine kinase (BTK) inhibitor.
- MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy.
- Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
- Measurable disease on cross sectional imagingtests that create detailed images of areas inside the body as defined in the protocol documented by diagnostic imagingtests that create detailed images of areas inside the body, also known as cancer imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0 or 1
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells, hepatic, and renal function as defined in the protocol