Last updated 19 days ago
A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
470 patients around the world
Available in Brazil, United States
Regeneron Pharmaceuticals
1Research sites
470Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Follicular lymphoma
Lymphoma
Marginal zone lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy.Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment, as described in the protocol.Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.Adequate hematologic and organ function, as described in the protocol.All study participants must have an understanding that lenalidomide could have a potential teratogenic risk.All study participants must agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.All study participants must agree not to share study medication with another person.All study participants must agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.
- Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol.Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.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 treated with hormone therapy or local radiotherapy (ie, pellets), 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.Allergy/hypersensitivity to study drugs or excipients, as described in the protocol.Active infection as defined in the protocol.
Sites
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Mãe de Deus Hospital
Recruiting
StudyOLYMPIA-5
SponsorRegeneron Pharmaceuticals
Study typeInterventional
Conditions
Follicular lymphomaMarginal zone lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06149286
