A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
Launched by REGENERON PHARMACEUTICALS · Oct 18, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new treatment for adults with follicular lymphoma, a type of cancer that affects the lymphatic system. The study is testing an experimental drug called odronextamab when combined with chemotherapy, to see if it is safe and effective compared to the standard treatment, which includes another drug called rituximab with chemotherapy. The trial is divided into three parts: the first part checks how well people tolerate the new drug and finds the right dose, while the second part compares its effectiveness against the standard treatment.
To participate in the trial, individuals need to have a specific type of follicular lymphoma that hasn't been treated before, and they must meet certain health requirements. Participants can expect to receive regular monitoring for side effects and to have their blood tested to see how the new drug is working in their body. This research aims not only to evaluate the effectiveness of the new treatment but also to understand its impact on patients’ daily lives and well-being. If you're considering this trial, it’s a chance to help advance treatment options for lymphoma.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
- • 1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
- • 2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
- • 3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
- • 2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography \[CT\], or magnetic resonance imaging \[MRI\] imaging, as described in the protocol
- • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- • 4. Adequate bone marrow and hepatic function.
- Key Exclusion Criteria:
- • 1. Participants with central nervous system lymphoma or leptomeningeal lymphoma
- • 2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- • 3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- • 4. Recent major surgery and history or organ transplantation
- • 5. A malignancy other than NHL unless the participant is adequately and definitively treated and 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.
- • Note: Other protocol-defined Inclusion/Exclusion criteria apply
About Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, a leading biotechnology company, is dedicated to transforming the lives of patients through innovative medicines. Founded in 1988, the company specializes in the discovery, development, and commercialization of cutting-edge therapies for serious diseases, leveraging advanced genetic technologies and a robust pipeline of novel drug candidates. With a strong focus on areas such as ophthalmology, oncology, immunology, and rare diseases, Regeneron is committed to scientific excellence and collaboration, striving to deliver safe and effective treatments that address unmet medical needs and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
Valencia, , Spain
Brussels, , Belgium
Liege, , Belgium
Milano, , Italy
Detroit, Michigan, United States
Liverpool, New South Wales, Australia
Madrid, , Spain
Valencia, , Spain
Detroit, Michigan, United States
Khon Kaen, , Thailand
Salamanca, , Spain
Tel Aviv, , Israel
Paris, , France
Truro, Cornwall, United Kingdom
Lugo, , Spain
Madrid, , Spain
Waratah, New South Wales, Australia
Sevilla, , Spain
Sevilla, , Spain
Petah Tikva, , Israel
Taipei, , Taiwan
Perugia, , Italy
Perugia, , Italy
Saint Etienne, , France
Istanbul, , Turkey
Tel Aviv, , Israel
Gdansk, , Poland
Bangkok, , Thailand
Wels, , Austria
Nantes, Pays De La Loire, France
Taipei City, , Taiwan
Grenoble, , France
Grand Rapids, Michigan, United States
Taipei, , Taiwan
Oviedo, , Spain
Majadahonda, , Spain
Potenza, , Italy
Majadahonda, Madrid, Spain
Aberdeen, Aberdeenshire, United Kingdom
Porto Alegre, Rio Grande Do Sul, Brazil
Ogden, Utah, United States
Madrid, , Spain
Madrid, , Spain
Haifa, , Israel
Lexington, Kentucky, United States
Graz, Styria, Austria
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Majadahonda, Madrid, Spain
Ourense, , Spain
Madrid, , Spain
Houston, Texas, United States
Pamplona, Navarra, Spain
Terrassa, Barcelona, Spain
Katowice, , Poland
Be'er Sheva, , Israel
Taipei City, , Taiwan
Waukesha, Wisconsin, United States
Toledo, , Spain
Benowa, Queensland, Australia
Sakarya, Serdivan, Turkey
Kiel, , Germany
Istanbul, , Turkey
Napoli, , Italy
Madrid, , Spain
Linz, Upper Austria, Austria
Ghent, East Flanders, Belgium
Sevilla, Andalusia, Spain
Westbury, New York, United States
Terrassa, , Spain
Truro, Cornwall, United Kingdom
Plantation, Florida, United States
Toledo, , Spain
Modena, , Italy
Ankara, , Turkey
Innsbruck, , Austria
Le Puy En Velay, , France
Kortrijk, West Flanders, Belgium
Samsun, , Turkey
Westbury, New York, United States
Samsun, Atakum, Turkey
Noblesville, Indiana, United States
Madrid, , Spain
Bydgoszcz, , Poland
Adapazari, Sakarya, Turkey
Yenimahalle, Ankara, Turkey
Tekirdag, Suleymanpasa, Turkey
Ankara, , Turkey
Tekirdag, , Turkey
Grand Rapids, Michigan, United States
Santiago, , Chile
Jerusalem, Yerushalayim, Israel
Katowice, Silesia, Poland
Madrid, , Spain
Pamplona, Navarre, Spain
Kayseri, , Turkey
Gent, Oost Vlaanderen, Belgium
Santiago, Region Metropolitana, Chile
Tours, Centre Val De Loire, France
Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand
Aberdeen, , United Kingdom
Sint Niklaas, East Flanders, Belgium
Verviers, Liege, Belgium
Brussels, , Belgium
Santiago, Santiago Metropolitan Region, Chile
Ravenna, Emilia Romagna, Italy
Meldola, Forli Cesena, Italy
Sabadell, Barcelona, Spain
Khon Kaen, , Thailand
Santiago, Las Condes, Chile
Tel Aviv, , Israel
Santiago, Region Metropolitana, Chile
Naples, Campania, Italy
Oviedo, Asturas, Spain
Taipei, , Taiwan
Khon Kaen, , Thailand
Leoben, Styria, Austria
Jerusalem, , Israel
Jerusalem, Jersualem, Israel
Milano, , Italy
Udine, , Italy
Krakow, Malopolskie, Poland
New Taipei City, New Taipei, Taiwan
Sao Paulo, , Brazil
Reggio Emilia, Emilia Romagna, Italy
Birmingham, West Midlands, United Kingdom
Perugia, Umbria, Italy
Walbrzych, , Poland
Liverpool, New South Wales, Australia
Gdansk, Pomeranian Voivodeship, Poland
Kaohsiung City, Kaohsiung, Taiwan
Alicante, Comunidad Valenciana, Spain
Bydgoszcz, Kuyavian Pomeranian Voivodeship, Poland
Walbrzych, Lower Silesian Voivodeship, Poland
Ankara, , Turkey
Mezitli, Mersin, Turkey
Ankara, , Turkey
Modena, Emilia Romagna, Italy
Pozuelo De Alarcon, Madrid, Spain
Argenteuil, Ile De France, France
Meldola (Fc), Forli Cesena, Italy
Krakow, Malopolskie, Poland
Ankara, Central Anatolia, Turkey
Sint Niklaas, Oost Vlaanderen, Belgium
Ravenna, , Italy
Reggio Emilia, , Italy
Sabadell, Barcelona, Spain
Pamplona, , Spain
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Istanbul, , Turkey
Istanbul, , Turkey
Kayseri, , Turkey
Birmingham, West Midlands, United Kingdom
Bruges, West Flanders, Belgium
Warszawa, , Poland
Zonguldak, , Turkey
Uxbridge, London, United Kingdom
Lodz, , Poland
Meldola, Forli Cesena, Italy
Santiago, Region Metropolitana, Chile
Lublin, , Poland
Sao Paulo, , Brazil
Skorzewo, Wielkopolska, Poland
Hradec Kralove, North Central Czech Republic, Czechia
Natal, Rio Grande Do Norte, Brazil
Lens, , France
Pessac, , France
Cannes, Alpes Maritimes, France
Nimes, Gard, France
Mont De Marsan, Nouvelle Aquitaine, France
Pessac, , France
Saint Nazaire, , France
Gdansk, , Poland
Saint Poelten, Lower Austria, Austria
Pisa, , Italy
Brasilia, Distrito Federal, Brazil
Belo Horizonte, Minas Gerais, Brazil
Ribeirao Preto, Sao Paulo, Brazil
Brno, South Moravian, Czechia
Cergy Pontoise, Pontoise, France
Torino, Piemonte, Italy
Patients applied
Trial Officials
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported