NCT06091254Recruiting
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
Summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.
Inclusion criteria
1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV 2. Need for treatment as described in the protocol 3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Adequate bone marrow function and hepatic function, as described in the protocol
Exclusion criteria
1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma 2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma 3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma 4. Treatment with any systemic anti-lymphoma therapy 5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Brazil, Canada, Chile, Czechia, Israel, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Regeneron Pharmaceuticals(Industry)
- Protocol no.
- R1979-HM-2298
- Conditions
- Follicular Lymphoma (FL)
- Interventions
- Drug
Treatments studied
- Odronextamab
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Vincristine
- Prednisone/prednisolone
- Bendamustine
Locations · 145
- Baden, SwitzerlandKantonsspital BadenRecruiting at this site
- Sankt Gallen, SwitzerlandCantonal Hospital St GallenRecruiting at this site
- Winterthur, SwitzerlandKantonsspital Winterthur Medical OncologyRecruiting at this site
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Bern, SwitzerlandInselspital Bern University HospitalRecruiting at this site
- Rennes, FranceCentre Hospitalier Universitaire (CHU) RennesRecruiting at this site
- Tours, FranceCentre Hospitalier Regional Universitaire de ToursRecruiting at this site
- Marseille, FranceHopital de la ConceptionRecruiting at this site
- Angers, FranceCentre Hospitalier Universitaire AngersRecruiting at this site
- Marseille, FranceInstitut Paoli CalmettesRecruiting at this site
- Paris, FranceHopital Saint LouisRecruiting at this site
- Paris, FranceHopital Saint-AntoineRecruiting at this site
- Strasbourg, FranceInstitut de Cancerologie Strasbourg Europe (ICANS)Recruiting at this site
- Argenteuil, FranceHopital Victor Dupouy ArgenteuilRecruiting at this site
- Villejuif, FranceGustave RoussyRecruiting at this site
- Würzburg, GermanyUniversity Hospital WurzburgRecruiting at this site
- Mutlangen, GermanyKliniken Ostalb Stauferklinikum Schwab GmundRecruiting at this site
- Mainz, GermanyUniversitatsmedizin der Johannes-Gutenberg Universitat MainzRecruiting at this site
- Dresden, GermanyHematological Praxis DresdenRecruiting at this site
- Berlin, GermanyCharite Universitatsmedizin Berlin Campus Benjamin FranklinRecruiting at this site
- Dresden, GermanyUniversity Hospital Carl Gustav CarusRecruiting at this site
- Kiel, GermanyStadtisches Krankenhaus KielRecruiting at this site
- Meldola, ItalyIstituto Romagnolo Per Lo Studio Dei TumoriRecruiting at this site
- Tricase, ItalyPia Fondazione PanicoRecruiting at this site
- Genoa, ItalyIRCCS Ospedale Policlinico San MartinoRecruiting at this site
- Candiolo, ItalyCandiolo Cancer Institute, FPO, IRCCSRecruiting at this site
- Brescia, ItalyAzienda Ospedaliera Spedali Civili di BresciaRecruiting at this site
- Milan, ItalyIstituto Europeo di OncologiaRecruiting at this site
- Novara, ItalyAOU Maggiore della Carita-SCDU EmatologiaRecruiting at this site
- Ravenna, ItalyUO Ematologia RavennaRecruiting at this site
In total, worldwide, 145 of the 190 sites listed in the registry are recruiting; the other 45 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 115 more locations
Other identifiers
- 2022-502660-20-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.