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 Participants With Follicular Lymphoma
Launched by REGENERON PHARMACEUTICALS · Oct 13, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new experimental drug called odronextamab to see if it is safe and effective for people with follicular lymphoma, a type of blood cancer. The trial has two parts: the first part will test how well the drug is tolerated when taken alone, while the second part will compare how well the drug works alongside chemotherapy and another medication called rituximab, which is the current standard treatment. The researchers will also look at side effects, how the drug behaves in the body, and how it affects the quality of life for participants.
To be eligible for this trial, participants must be diagnosed with a specific type of follicular lymphoma and need treatment. They should be aged between 65 and 74 years, have a good performance status (meaning they can carry out daily activities), and have no recent significant health issues that would interfere with the study. If you join the trial, you can expect regular check-ups, tests to monitor your health, and the opportunity to contribute to important research that may help others with this condition.
Gender
ALL
Eligibility criteria
- Key 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
- Key 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
- • 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
Brussels, , Belgium
Boston, Massachusetts, United States
Milano, , Italy
Saint John, New Brunswick, Canada
Madrid, , Spain
Valencia, , Spain
Malaga, , Spain
Paris, , France
Murcia, , Spain
Santander, , Spain
Nashville, Tennessee, United States
Los Angeles, California, United States
Haifa, , Israel
Chapel Hill, North Carolina, United States
Taipei, , Taiwan
Barcelona, , Spain
Tucson, Arizona, United States
Calgary, Alberta, Canada
Detroit, Michigan, United States
Salamanca, , Spain
Bedford Park, South Australia, Australia
Taipei, , Taiwan
Tel Aviv, , Israel
Paris, , France
Marseille, , France
Porto Alegre, , Brazil
Richmond, Virginia, United States
Basel, , Switzerland
Stony Brook, New York, United States
Baden, Aargau, Switzerland
Santander, Cantabria, Spain
Granada, , Spain
Vienna, , Austria
Villejuif, , France
Dresden, , Germany
St. Gallen, , Switzerland
Marseille, , France
Sevilla, , Spain
Nahariya, , Israel
Taichung, , Taiwan
Zaragoza, , Spain
Sevilla, , Spain
Tainan, , Taiwan
Hradec Kralove, , Czechia
Petah Tikva, , Israel
Petah Tikva, , Israel
Barcelona, , Spain
Kaohsiung, , Taiwan
Norwich, Norfolk, United Kingdom
Hattiesburg, Mississippi, United States
Vienna, , Austria
Valencia, , Spain
Napoli, , Italy
Charlotte, North Carolina, United States
Brescia, , Italy
Cleveland, Ohio, United States
Taipei City, , Taiwan
Kayseri, , Turkey
Barcelona, , Spain
Salamanca, , Spain
Sevilla, , Spain
Oviedo, , Spain
Pamplona, Navarra, Spain
A Coruna, , Spain
Pamplona, , Spain
Istanbul, , Turkey
Izmir, , Turkey
Sevilla, Andalucia, Spain
Angers, , France
Gdansk, Pomorskie, Poland
Linz, , Austria
Porto Alegre, Rio Grande Do Sul, Brazil
Kaohsiung, , Taiwan
Melbourne, Victoria, Australia
New Taipei City, , Taiwan
Izmir, , Turkey
Madrid, , Spain
Kaohsiung, , Taiwan
Orange, California, United States
Busan, , Korea, Republic Of
Santiago De Compostela, , Spain
Oviedo, Asturias, Spain
Suwon Si, Gyeonggi Do, Korea, Republic Of
Los Angeles, California, United States
Nahariya, , Israel
El Palmar, Murcia, Spain
Nantes, Loire Atlantique, France
Clayton, Victoria, Australia
New York, New York, United States
Linz, , Austria
Seoul, , Korea, Republic Of
Ourense, , Spain
Petah Tikva, , Israel
Changhua City, Changhua County, Taiwan
Tyler, Texas, United States
Houston, Texas, United States
Ankara, , Turkey
Pamplona, Navarra, Spain
Katowice, , Poland
Orange, California, United States
Pozuelo De Alarcon, Madrid, Spain
Palma De Mallorca, , Spain
Barakaldo, , Spain
Charlotte, North Carolina, United States
Glasgow, Lanarkshire, United Kingdom
Bern, , Switzerland
Waukesha, Wisconsin, United States
Petah Tikva, , Israel
Udine, , Italy
Madrid, , Spain
Ankara, , Turkey
Brescia, , Italy
Kiel, , Germany
Madrid, , Spain
Calgary, , Canada
Quebec, , Canada
New Taipei, , Taiwan
Antwerp, , Belgium
Taipei City, , Taiwan
Madrid, , Spain
Sao Paulo, , Brazil
Paris, , France
Napoli, , Italy
Madrid, , Spain
Truro, , United Kingdom
Ashdod, , Israel
Poitiers, , France
Linz, , Austria
Milan, , Italy
Madrid, , Spain
Santiago, Region Metropolitana, Chile
Walbrzych, , Poland
Tyler, Texas, United States
Winterthur, , Switzerland
Taoyuan, , Taiwan
Taipei, , Taiwan
Ashdod, , Israel
Krakow, Malopolskie, Poland
Prague, , Czechia
Palma, , Spain
Kiel, , Germany
Valencia, , Spain
Angers, , France
Pamplona, , Spain
Sakarya, , Turkey
Auchenflower, Queensland, Australia
Tricase, Lecce, Italy
Toledo, , Spain
Samsun, , Turkey
Changhua City, , Taiwan
Noblesville, Indiana, United States
Meldola, , Italy
Ravenna, , Italy
Nahariya, , Israel
Lages, , Brazil
Gdansk, , Poland
Varese, , Italy
Ankara, , Turkey
Krakow, , Poland
Glasgow, , United Kingdom
Taipei, , Taiwan
Genova, , Italy
Romford, , United Kingdom
Strasbourg, , France
Pamplona, , Spain
Busan, Seo Gu, Korea, Republic Of
Westbury, New York, United States
Noblesville, Indiana, United States
Praha, , Czechia
Ankara, , Turkey
Tyler, Texas, United States
Lages, Santa Catarina, Brazil
Strasbourg, , France
Seville, , Spain
Yenimahalle, Ankara, Turkey
Tekirdag, Suleymanpasa, Turkey
Fitzroy, Victoria, Australia
Houston, Texas, United States
Istanbul, , Turkey
Tekirdag, , Turkey
Palma, Balearic Islands, Spain
Granada, , Spain
Mainz, , Germany
Novara, , Italy
Hradec Kralove 5, , Czechia
Skorzewo, , Poland
Pozuelo De Alarcon, , Spain
New York, New York, United States
Auchenflower, Queensland, Australia
Krakow, Malopolska, Poland
Charlottesville, Virginia, United States
Norwich, Norfolk, United Kingdom
East Melbourne, Victoria, Australia
Gent, Oost Vlaanderen, Belgium
Santiago, Region Metropolitana, Chile
East Melbourne, Victoria, Australia
Las Condes, , Chile
Jerusalem, , Israel
Ramat Gan, , Israel
Candiolo, , Italy
Taoyuan City, Taoyuan County, Taiwan
Plymouth, Devon, United Kingdom
Rennes, Bretagne, France
Dresden, Sachsen, Germany
Chapel Hill, North Carolina, United States
Tel Aviv, , Israel
Toledo, , Spain
Baden, , Switzerland
Kaohsiung, , Taiwan
Santiago, , Chile
Madrid, , Spain
Würzburg, , Germany
Jeonju, Deokjin Gu, Korea, Republic Of
Charlottesville, Virginia, United States
Tucson, Arizona, United States
Fitzroy, , Australia
Las Condes, Región Metropolitana De Santiago, Chile
Providencia, Santiago, Chile
Praha 10, Vinohrady, Czechia
Hradec Kralove 5, , Czechia
Argenteuil, , France
Nantes, , France
Poitiers, , France
Tours Cedex 09, , France
Dresden, , Germany
Ascoli Piceno, , Italy
Bologna, , Italy
Udine, , Italy
Puzi City, Chiayi, Taiwan
Neihu, Taipei, Taiwan
Romford, , United Kingdom
Jerusalem, , Israel
Sao Paulo, , Brazil
Liverpool, New South Wales, Australia
Melbourne, Victoria, Australia
Salzburg, , Austria
Greenfield Park, Quebec, Canada
Sherbrooke, Quebec, Canada
Taoyuan, Taoyuan County, Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Samsun, , Turkey
Cornwall, , United Kingdom
Mezitli, Mersin, Turkey
Fitzroy, Victoria, Australia
Prague, , Czechia
Rennes Cedex 9, , France
Dresden, , Germany
Nahariya, , Israel
Bologna, , Italy
Meldola, , Italy
Madrid, , Spain
Murcia, , Spain
Pamplona, , Spain
Sevilla, , Spain
Valencia, , Spain
Bern, , Switzerland
New Taipei, , Taiwan
Mezitli, Mersin, Turkey
Bournemouth, Hampshire, United Kingdom
Ramat Gan, , Israel
Walbrzych, Lower Silesian, Poland
Ankara, , Turkey
Herentals, Antwerp, Belgium
Argenteuil, Ile De France, France
Frankfurt, Hesse, Germany
Madrid, , Spain
Istanbul, , Turkey
Sakarya, , Turkey
Taichung, , Taiwan
Ravenna, , Italy
Istanbul, , Turkey
Kayseri, , Turkey
Liverpool, New South Wales, Australia
Linz, Osterreich, Austria
Salzburg, , Austria
Greenfield Park, Quebec, Canada
Sherbrooke, Quebec, Canada
Quebec City, , Canada
Santiago, Region Metropolitana, Chile
Hradec Kralove, Czech Republic, Czechia
Praha, , Czechia
Rennes, Bretagne, France
Tours, Centre Val De Loire, France
Marseille, Provence Alpes Cote D'azur, France
Paris, , France
Strasbourg, , France
Mainz, Rheinland Pfalz, Germany
Meldola, Forli Cesena, Italy
Bologna, Italia, Italy
Genoa, Liguria, Italy
Candiolo, Torino, Italy
Ascoli Piceno, , Italy
Novara, , Italy
Varese, , Italy
Poznan, Wielkopolska, Poland
Santiago De Compostela, A Coruna, Spain
Malaga, Andalucia, Spain
Barakaldo, Bizkaia, Spain
A Coruna, Galicia, Spain
Madrid, , Spain
Murcia, , Spain
Valencia, , Spain
St Gallen, Saint Gallen, Switzerland
Winterthur, Schweiz, Switzerland
Taoyuan City, Guishan District, Taiwan
Chiayi City, , Taiwan
Truro, Cornwall, United Kingdom
Plymouth, Devon, United Kingdom
Bournemouth, Dorset, United Kingdom
Valencia, , Spain
Zonguldak, , Turkey
Salzburg, , Austria
Suwon Si, Gyeonggi Do, Korea, Republic Of
Greenfield Park, Quebec, Canada
Quebec City, Quebec, Canada
Wroclaw, Dolnoslaskie, Poland
Skorzewo Poznan, Wielkopolska, Poland
Mutlangen, Gmund, Germany
Goyang, Gyeonggi Do, Korea, Republic Of
Kaohsiung, , Taiwan
Poznan, Wielkopolska, Poland
Valencia, , Spain
Lublin, , Poland
Joinville, Santa Catarina, Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Würzburg, Bavaria, Germany
Skorzewo, Wielkopolska, Poland
Natal, Rio Grande Do Norte, Brazil
Passo Fundo, Rio Grande Do Sul, Brazil
Jau, Sao Paulo, Brazil
Ribeirao Preto, Sao Paulo, Brazil
Lodz, , Poland
Sherbrooke, Quebec, Canada
Berlin, , Germany
Puzi City, Chiayi County, Taiwan
Belo Horizonte, Minas Gerais, Brazil
Brasilia, , Brazil
Santiago, , Chile
Warszawa, , Poland
Barretos, Sao Paulo, Brazil
Salt Lake City, Utah, United States
Haine Saint Paul, Hainaut, Belgium
Salvador, Bahia, Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Paris, , France
Mamak, Ankara, Turkey
Patients applied
Trial Officials
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported