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Search / Trial NCT06149286

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 24, 2025

Recruiting

Keywords

Relapsed/Refractory Follicular Lymphoma Marginal Zone Lymphoma Non Hodgkin Lymphomas Indolent Lymphomas Odronextamab

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.

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

0 patients applied

Trial Officials

Clinical Trial Management

Study Director

Regeneron Pharmaceuticals

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported