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
Launched by REGENERON PHARMACEUTICALS · Nov 20, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for adults with two specific types of cancer: follicular lymphoma and marginal zone lymphoma, especially for those whose cancer has returned after treatment or did not respond to previous treatments. The trial is testing a combination of an experimental drug called odronextamab with lenalidomide, comparing it to the standard treatment, which is rituximab combined with lenalidomide. The goal is to see if the new combination is safe and more effective than the standard treatment.
To participate in this trial, individuals must be diagnosed with either follicular lymphoma or marginal zone lymphoma, have had at least one prior treatment, and have measurable disease as seen on imaging tests like CT scans or MRIs. Participants can expect to receive the study drug along with lenalidomide and be monitored for side effects and how well the treatment works. The trial aims to understand not only the effectiveness of the new treatment but also how it affects daily life and well-being. It’s important for participants to discuss any potential risks, especially related to pregnancy, before joining the study.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. 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.
- • 2. 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.
- • 3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or magnetic resonance imaging \[MRI\] imaging, as described in the protocol.
- • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- • 5. Adequate hematologic and organ function, as described in the protocol.
- 6. All study participants must:
- • 1. Have an understanding that lenalidomide could have a potential teratogenic risk.
- • 2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.
- • 3. Agree not to share study medication with another person.
- • 4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.
- Key Exclusion Criteria:
- • 1. 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.
- • 2. 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.
- • 3. History of or current relevant CNS pathology, as described in the protocol.
- • 4. 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.
- • 5. 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.
- • 6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
- • 7. Active infection as defined 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
Valencia, , Spain
Brussels, , Belgium
Paris, , France
Milano, , Italy
Hobart, Tasmania, Australia
Barcelona, , Spain
Los Angeles, California, United States
Seoul, , Korea, Republic Of
Indianapolis, Indiana, United States
Salamanca, , Spain
Paris, , France
Stony Brook, New York, United States
Santander, Cantabria, Spain
Granada, , Spain
Bournemouth, Dorset, United Kingdom
Chiang Mai, , Thailand
Madrid, , Spain
Rennes, , France
Waratah, New South Wales, Australia
Villejuif, , France
Nantes, , France
Kota Kinabalu, Sabah, Malaysia
Wels, , Austria
Barcelona, , Spain
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Petah Tikva, , Israel
Seoul, , Korea, Republic Of
Perugia, , Italy
Hattiesburg, Mississippi, United States
Pavia, , Italy
Seoul, , Korea, Republic Of
Bangkok, , Thailand
Johor Bahru, Johor, Malaysia
Brescia, , Italy
Kuala Lumpur, , Malaysia
Nantes, Pays De La Loire, France
Taipei City, , Taiwan
Westbury, New York, United States
Barcelona, , Spain
Brno, , Czechia
Kiel, , Germany
Taipei, , Taiwan
Great Yarmouth, , United Kingdom
Izmir, , Turkey
Wels, , Austria
Gdansk, Pomorskie, Poland
Busan, , Korea, Republic Of
Taipei City, , Taiwan
Avignon, , France
Valencia, , Spain
Madrid, , Spain
Warwick, , United Kingdom
Seville, , Spain
Busan, , Korea, Republic Of
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Oviedo, Asturias, Spain
Daegu, , Korea, Republic Of
Romford, Essex, United Kingdom
Nahariya, , Israel
Ampang, Selangor, Malaysia
Ulsan, , Korea, Republic Of
Romford, Essex, United Kingdom
Ravenna, , Italy
Seoul, Jongno Gu, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Katowice, , Poland
Chiayi City, , Taiwan
Pozuelo De Alarcón, Madrid, Spain
Pozuelo De Alarcon, Madrid, Spain
Yvoir, , Belgium
Waukesha, Wisconsin, United States
Incheon, Namdong Gu, Korea, Republic Of
Suwon, , Korea, Republic Of
Udine, , Italy
Perugia, , Italy
Benowa, Queensland, Australia
Genova, , Italy
Novara, , Italy
Madrid, , Spain
Kiel, , Germany
Madrid, , Spain
Plymouth, Devon, United Kingdom
Antwerp, , Belgium
Taoyuan City, , Taiwan
Izmir, , Turkey
Napoli, , Italy
New Taipei City, , Taiwan
Taoyuan City, , Taiwan
Linz, Upper Austria, Austria
Roeselare, West Flanders, Belgium
Praha, , Czechia
Ashdod, , Israel
Prague, , Czechia
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Santiago De Compostela, A Coruña, Spain
Sakarya, , Turkey
Tainan City, , Taiwan
Roeselare, West Vlaanderen, Belgium
Villejuif, île De France, France
Plantation, Florida, United States
Changhua City, , Taiwan
Modena, , Italy
Taipei, , Taiwan
Bangkok, , Thailand
Westbury, New York, United States
Bydgoszcz, , Poland
Waukesha, Wisconsin, United States
Seville, , Spain
Yenimahalle, Ankara, Turkey
Tekirdag, Suleymanpasa, Turkey
Bangkok, , Thailand
Ankara, , Turkey
Palma, Balearic Islands, Spain
Granada, , Spain
Valencia, , Spain
Poznan, Wielkopolska, Poland
Palma, Balearic Islands, Spain
Chambery, Savoie, France
Madrid, , Spain
Poznan, Wielkopolska, Poland
Bordeaux Cedex, Gironde, France
Argenteuil, île De France, France
Daegu, , Korea, Republic Of
Pessac, Gironde, France
Monza, Monza E Brianza, Italy
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Krakow, Malopolska, Poland
Santander, Cantabria, Spain
Yenimahalle, Ankara, Turkey
Tekirdag, Suleymanpasa, Turkey
East Melbourne, Victoria, Australia
Gent, Oost Vlaanderen, Belgium
Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand
Stony Brook, New York, United States
East Melbourne, Victoria, Australia
Brussels, , Belgium
Hradec Kralove 5, , Czechia
Paris, , France
Tours, Centre Val De Loire, France
Bordeaux Cedex, Gironde, France
Lille Cedex, Nord, France
Meldola (Fc), Forli Cesena, Italy
Candiolo, Torino, Italy
Busan, , Korea, Republic Of
Tel Aviv, , Israel
Rouen, Normandie, France
Bobigny, Ile De France, France
Napoli, , Italy
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Brescia, , Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Aviano, , Italy
Bologna, , Italy
Villejuif, Val De Marne / Ile De France, France
Jerusalem, , Israel
Ankara, , Turkey
Linz, Upper Austria, Austria
Udine, , Italy
Kuala Lumpur, Negeri/Wilayah Persekutuan, Malaysia
Madrid, , Spain
Tainan City, , Taiwan
Truro, Cornwall, United Kingdom
Subang Jaya, Selangor, Malaysia
Uxbridge, Middx, United Kingdom
Linz, österreich, Austria
Montpellier, , France
Ashdod, , Israel
Jerusalem, , Israel
Nahariya, , Israel
Salisbury, Hampshire, United Kingdom
Samsun, , Turkey
Mezitli, Mersin, Turkey
Ramat Gan, , Israel
Sydney, New South Wales, Australia
Walbrzych, Lower Silesian, Poland
Hradec Kralove, East Bohemia, Czechia
Argenteuil, Ile De France, France
Lille, Nord, France
Paris, , France
Frankfurt, Hesse, Germany
Meldola (Fc), Forli Cesena, Italy
Seoul, , Korea, Republic Of
Madrid, , Spain
Puzi City, , Taiwan
Sakarya, , Turkey
Seoul, , Korea, Republic Of
Johor Bahru, Johor, Malaysia
Ankara, Central Anatolia, Turkey
Kaohsiung City, , Taiwan
Linz, Osterreich, Austria
Tours, Centre Val De Loire, France
Candiolo, Torino, Italy
Santiago De Compostela, A Coruna, Spain
Plymouth, Devon, United Kingdom
Seoul, , Korea, Republic Of
Indianapolis, Indiana, United States
Liverpool, New South Wales, Australia
Vienna, , Austria
Yvoir, , Belgium
Rennes, Bretagne, France
Pessac, Gironde, France
Montpellier, , France
Monza, Monza E Brianza, Italy
Bologna, , Italy
Suwon Si, Gyeonggi Do, Korea, Republic Of
Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia
Madrid, , Spain
Zonguldak, , Turkey
Bournemouth, Dorset, United Kingdom
Salisbury, Hampshire, United Kingdom
Uxbridge, Middlesex, United Kingdom
Istanbul, , Turkey
Wroclaw, Dolnoslaskie, Poland
Mutlangen, Baden Wuerttemberg, Germany
Milan, , Italy
Stuttgart, Baden Wurttemberg, Germany
Lodz, , Poland
Meldola, Forli Cesena, Italy
Skorzewo, Wielkopolska, Poland
Sakarya, , Turkey
Jeonju, Jeollabuk, Korea, Republic Of
Warsaw, , Poland
Puzi City, Chiayi County, Taiwan
Changhua City, , Taiwan
Lublin, , Poland
Marseille, Bouches Du Rhone, France
Aviano, Province Of Pordenone, Italy
Patients applied
Trial Officials
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported