Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma
Launched by GENMAB · Dec 20, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for adults with follicular lymphoma (FL), a common type of blood cancer. Researchers want to find out how safe and effective a combination of three treatments—epcoritamab (an experimental drug), rituximab (given through an IV), and lenalidomide (taken as a pill)—is for patients who have never been treated for this condition before. The trial will include about 1,080 participants from various locations worldwide, who will be divided into different groups to receive either the new combination treatment or standard chemotherapy options.
To join the trial, participants must be adults diagnosed with follicular lymphoma that is at least stage II and need treatment. They should also have specific measurable signs of the disease confirmed by medical scans. Participants will have regular hospital visits over a total treatment period of about 120 weeks, where they will receive their medication and undergo tests to monitor their health and any side effects. It's important to note that participating in this trial may involve more frequent visits and procedures than standard treatments.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of follicular lymphoma (FL).
- • Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
- • Are willing and able to comply with procedures required in the protocol.
- • Must have stage, III, IV or II with bulky disease \>= 7cm).
- • Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
- * Has one or more target lesions:
- • A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
- • \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
- • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- • Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\].
- • Have laboratory values meeting the criteria in the protocol.
- Exclusion Criteria:
- • Had major surgery within 4 weeks prior to randomization.
- • Have active cytomegalovirus (CMV) disease.
About Genmab
Genmab is a leading biotechnology company focused on the development and commercialization of innovative antibody therapeutics for the treatment of cancer and other serious diseases. Founded in 1999 and headquartered in Copenhagen, Denmark, Genmab leverages its proprietary antibody technology platforms to create differentiated therapies that address unmet medical needs. The company's robust pipeline includes several promising candidates in various stages of clinical development, reflecting its commitment to advancing the field of immunotherapy and improving patient outcomes. Through strategic collaborations and a strong focus on scientific excellence, Genmab aims to transform the landscape of cancer treatment and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Des Moines, Iowa, United States
Bethesda, Maryland, United States
Chesterfield, Missouri, United States
Billings, Montana, United States
Toledo, Ohio, United States
Olympia, Washington, United States
Rio Piedras, , Puerto Rico
Billings, Montana, United States
Fort Wayne, Indiana, United States
Louisville, Kentucky, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Peoria, Illinois, United States
Louisville, Kentucky, United States
Bethesda, Maryland, United States
Westbury, New York, United States
Toledo, Ohio, United States
Greenville, South Carolina, United States
Seattle, Washington, United States
Melbourne, New South Wales, Australia
Westmead, New South Wales, Australia
Douglas, Queensland, Australia
Perth, Western Australia, Australia
Afula, H Efa, Israel
Be'er Sheva, Hadarom, Israel
Kfar Saba, Hamerkaz, Israel
Tel Aviv, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Seongnam Si, Gyeonggido, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bucharest, Bucuresti, Romania
Bucharest, , Romania
Belgrade, , Serbia
Novi Sad, , Serbia
Barcelona, , Spain
Madrid, , Spain
Taipei City, Taipei, Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Orlando, Florida, United States
Coeur D'alene, Idaho, United States
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
Lubbock, Texas, United States
Woolloongabba, Queensland, Australia
Frankston, Victoria, Australia
Brasschaat, Limburg, Belgium
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Rijeka, Primorsko Goranska Zupanija, Croatia
Split, Splitsko Dalmatinska Zupanija, Croatia
Zadar, , Croatia
Hradec Kralove, , Czechia
Praha, , Czechia
Avignon, Haute Corse, France
Nantes Cedex 2, Loire Atlantique, France
Pierre Benite Cedex, Rhone, France
Le Mans Cedex 9, Sarthe, France
Caen, , France
Paris, , France
Karlsruhe, Baden Wuerttemberg, Germany
Kassel, Hessen, Germany
Ludwigshafen Am Rhein, Rheinland Pfalz, Germany
Magdeburg, , Germany
Szombathely, Vas, Hungary
Ramat Gan, Tel Aviv, Israel
Candiolo, Torino, Italy
Palermo, , Italy
Fukuoka Shi, Fukuoka, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Bergen Op Zoom, Noord Brabant, Netherlands
Den Haag, Zuid Holland, Netherlands
Groningen, , Netherlands
Grafton, Auckland, New Zealand
Krakow, Malopolskie, Poland
Warszawa, Mazowieckie, Poland
Lisbon, Lisboa, Portugal
Vila Nova De Gaia, Porto, Portugal
Lisboa, Regiao Autonoma Da Madeira, Portugal
San Juan, , Puerto Rico
Jassi, Iasi, Romania
Cluj Napoca, Olt, Romania
Belgrade, Beograd, Serbia
Belgrade, Pomoravski Okrug, Serbia
Sremska Kamenica, Vojvodina, Serbia
Santander, Cantabria, Spain
Pamplona, Navarra, Spain
Caceres, , Spain
Salamanca, , Spain
Taichung, Keelung, Taiwan
Tainan, Keelung, Taiwan
Billings, Montana, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Rio Rancho, New Mexico, United States
Albany, New York, United States
Troy, New York, United States
Maumee, Ohio, United States
Roeselare, West Vlaanderen, Belgium
Pleven, Smolyan, Bulgaria
Sofia, Smolyan, Bulgaria
Sofia, , Bulgaria
Odense, Syddanmark, Denmark
Libourne, , France
Paris, , France
Frankfurt Am Main, Hessen, Germany
Patras, Achaia, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Alexandroupolis, , Greece
Athens, , Greece
Gyor, Gyor Moson Sopron, Hungary
Szekszard, Tolna, Hungary
Budapest, , Hungary
Haifa, , Israel
Toyoake, Aichi, Japan
Yoshida Gun, Fukui, Japan
Osakasayama Shi, Osaka, Japan
Chuo, Yamanashi, Japan
Nieuwegein, Utrecht, Netherlands
Amsterdam, Zuid Holland, Netherlands
Leiden, Zuid Holland, Netherlands
Rotterdam, Zuid Holland, Netherlands
Lodz, Lodzkie, Poland
Lisboa, , Portugal
Pretoria, Gauteng, South Africa
Samsun, , Turkey
Newcastle Upon Tyne, , United Kingdom
Louisville, Kentucky, United States
Scarborough, Maine, United States
Omaha, Nebraska, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Gent, Oost Vlaanderen, Belgium
Zagreb, Grad Zagreb, Croatia
Strasbourg, , France
Palermo, , Italy
Matsuyama Shi, Ehime, Japan
Fukushima Shi, Fukushima, Japan
Sapporo, Hokkaido, Japan
Kobe Shi, Hyogo, Japan
Hitachi, Ibaraki, Japan
Sagamihara, Kanagawa, Japan
Okayama Shi, Okayama, Japan
Hirakata Shi, Osaka, Japan
Ube, Yamaguchi, Japan
Aomori, , Japan
Chiba, , Japan
Amsterdam, Zuid Holland, Netherlands
Takapuna, Auckland, New Zealand
Porto, , Portugal
Kragujevac, Pomoravski Okrug, Serbia
Boras, Vastra Gotalands Lan, Sweden
Kocaeli, Adana, Turkey
London, London, City Of, United Kingdom
Orlando, Florida, United States
Baltimore, Maryland, United States
New York, New York, United States
Houston, Texas, United States
Camperdown, New South Wales, Australia
Liverpool, New South Wales, Australia
Herston, Queensland, Australia
Murdoch, Western Australia, Australia
Brasschaat, Antwerpen, Belgium
Liege, , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Tianjin, Tianjin, China
Zagreb, Grad Zagreb, Croatia
Hradec Kralove, , Czechia
Roskilde, Sjælland, Denmark
Vejle, Syddanmark, Denmark
Avignon, Provence Alpes Cote D Azur, France
Eschweiler, Nordrhein Westfalen, Germany
Reggio Emilia, , Italy
Fukuyama, Hiroshima, Japan
Yokohama Shi, Kanagawa, Japan
Bunkyo Ku, Tokyo, Japan
Amsterdam, Noord Holland, Netherlands
Cluj Napoca, Cluj, Romania
Belgrade, Beograd, Serbia
Bratislava, Bratislavsky Kraj, Slovakia
Martin, Zilinsky Kraj, Slovakia
Badalona, Barcelona, Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Kocaeli, , Turkey
Plymouth, Devon, United Kingdom
London, Greater London, United Kingdom
Boulder, Colorado, United States
Newark, Delaware, United States
Cincinnati, Ohio, United States
Eugene, Oregon, United States
Austin, Texas, United States
Dallas, Texas, United States
Fairfax, Virginia, United States
Roanoke, Virginia, United States
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Wuhan, Hubei, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Hradec Králové, Hradec Kralove, Czechia
Herning, Midtjylland, Denmark
Bologna, Emilia Romagna, Italy
Roma, , Italy
Bunkyo Ku, Tokyo, Japan
Tilburg, Noord Brabant, Netherlands
Arnhem, , Netherlands
Kielce, Swietokrzyskie, Poland
Kuilsrivier, Western Cape, South Africa
L'hospitalet De Llobregat, Barcelona, Spain
London, England, United Kingdom
Leeds, West Yorkshire, United Kingdom
Manchester, , United Kingdom
Chicago, Illinois, United States
Santa Barbara, California, United States
Jacksonville, Florida, United States
Decatur, Illinois, United States
Des Moines, Iowa, United States
Westbrook, Maine, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Tacoma, Washington, United States
Bruxelles, Bruxelles Capitale, Belgium
Montréal, Quebec, Canada
Beijing, Beijing, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Suzhou, Jiangsu, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Chengdu, Sichuan, China
Urumqi, Xinjiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Hradec Králové, Hradec Kralove, Czech Republic
Praha, , Czech Republic
Petah Tikva, , Israel
Bologna, , Italy
Fukuoka Shi, Fukuoka, Japan
Sagamihara Shi, Kanagawa, Japan
Kragujevac, Sumadijski Okrug, Serbia
Izmir, , Turkey
Portsmouth, Hampshire, United Kingdom
Winston Salem, North Carolina, United States
Roskilde, , Denmark
Afula, , Israel
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported