Study on the Effectiveness and Safety of Odronextamab in Adults with B-cell Non-Hodgkin Lymphoma Previously Treated with Other Cancer Therapies

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03888105

Provider View

This clinical trial is testing a new drug called odronextamab to see if it can effectively destroy cancer cells in adults with B-cell Non-Hodgkin's Lymphoma (B-NHL) who have already tried other treatments. The study also aims to learn more about the safety of odronextamab and how it behaves in the body.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the investigational drug odronextamab works in treating B-cell Non-Hodgkin's Lymphoma (B-NHL) in adults who have previously received other cancer treatments. Researchers are looking to see if odronextamab can effectively kill cancer cells, understand any side effects it may cause, and learn how it works in the body and how much of it is present in the blood.

Eligibility Criteria

Inclusion Criteria

  • Patients with specific types of B-cell Non-Hodgkin's Lymphoma (B-NHL) that have returned or not responded to at least two previous treatments.
    • For Follicular Lymphoma (FL) grade 1-3a: Must have a confirmed diagnosis and have relapsed or refractory disease after at least two prior treatments.
    • For Diffuse Large B-Cell Lymphoma (DLBCL): Must have relapsed or refractory disease after at least two prior treatments.
    • For Mantle Cell Lymphoma (MCL) after BTK inhibitor therapy: Must have relapsed or refractory disease after at least one prior treatment and have been treated with a BTK inhibitor.
    • For Marginal Zone Lymphoma (MZL): Must have relapsed or refractory disease after at least two prior treatments.
    • For other B-NHL types: Must have relapsed or refractory disease after at least two prior treatments, excluding Burkitt lymphoma and Burkitt-like lymphoma.
  • Must have measurable disease as shown by imaging tests like CT or MRI.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate bone marrow, liver, and kidney function.

Exclusion Criteria

  • Have primary central nervous system (CNS) lymphoma or known involvement of the CNS by non-primary CNS Non-Hodgkin Lymphoma (NHL).
  • Have received any anti-lymphoma treatment within a short period before starting the study drug.
  • Have a history of receiving a stem cell transplant from a donor.
  • Are on continuous high-dose steroid treatment.
  • Have a history of certain brain or movement disorders, or seizures within the past year.
  • Have had another type of cancer in the past five years, except for certain skin or cervical cancers that have been treated.
  • Have uncontrolled infections like HIV, hepatitis B or C, or cytomegalovirus (CMV).
  • Have known allergies to both allopurinol and rasburicase.
  • Have previously been treated with a specific type of bispecific therapy targeting CD20 and CD3.

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