A trial to learn how effective and safe odronextamab is compared to standard of care for previously treated adult participants with aggressive B-cell non-Hodgkin Lymphoma.
- Conditions
- B-Cell Non-Hodgkin's LymphomaMedDRA version: 23.0Level: PTClassification code: 10029609Term: Non-Hodgkin's lymphoma unspecified histology aggressive recurrent Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2022-502783-21-00
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 225
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 or Magnetic resonance imaging), Intent to proceed to Autologous stem cell transfer., Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1., Adequate hematologic and organ function., Other protocol defined inclusion criteria apply
Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol., History of or current relevant CNS pathology, as described in the protocol., 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., 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., Prior treatments and infections, as described in the protocol., Allergy/hypersensitivity to study drug, or excipients., Other protocol defined exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method