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

Launched by REGENERON PHARMACEUTICALS · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called odronextamab to see how effective and safe it is for adults with aggressive B-cell non-Hodgkin lymphoma (B-NHL) that has not responded to previous treatments or has come back after treatment. The trial aims to find out how well this drug works compared to the usual care patients receive. Researchers will also look at potential side effects, how the drug behaves in the body, and how it affects patients' quality of life and daily activities.

To be eligible for this trial, participants must be adults aged 65 or older who have been diagnosed with aggressive B-NHL and have already received at least one prior treatment that included a specific type of antibody. They should have measurable disease with certain sized tumors and plan to undergo a specific type of stem cell transplant. Participants can expect to receive the study drug and will be monitored closely for any side effects or changes in their condition. This trial is currently recruiting participants, and there are additional criteria that need to be met for enrollment.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. 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
• • 2. 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
• • 3. 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 \[MRI\])
• • 4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• • 6. Adequate hematologic and organ function.
• Key Exclusion Criteria:
• • 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
• • 2. History of or current relevant CNS pathology, as described in the protocol
• • 3. 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
• • 4. 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
• • 5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
• • 6. Allergy/hypersensitivity to study drug, or excipients.
• • NOTE: Other protocol defined inclusion / exclusion criteria apply