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
NCT ID: NCT06149286
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
470 participants
INTERVENTIONAL
2023-12-28
2029-01-23
Brief Summary
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This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before.
The aim of Part 2, of the study is to assess how the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of care treatment for FL and/or MZL. Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug in combination with lenalidomide
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* The impact from the study drug on quality of life and ability to complete routine daily activities
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Odronextamab+Lenalidomide
In part 1 (safety run-in), participants with R/R indolent lymphoma (FL and MZL), will receive odronextamab in combination with lenalidomide.
In part 2, 1:1 randomized participants with indolent lymphoma (FL/MZL), will receive odronextamab in combination with lenalidomide.
Odronextamab
Administered by intravenous (IV) infusion
Lenalidomide
Administered orally (PO)
Rituximab+Lenalidomide
In part 2 only, 1:1 randomized participants with R/R lymphoma (FL and ML), will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy.
Lenalidomide
Administered orally (PO)
Rituximab
Administered by IV infusion, or subcutaneously (SC)
Interventions
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Odronextamab
Administered by intravenous (IV) infusion
Lenalidomide
Administered orally (PO)
Rituximab
Administered by IV infusion, or subcutaneously (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, United States
Indiana University and Comprehensive Cancer Center
Indianapolis, Indiana, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
Prohealth Care Inc
Waukesha, Wisconsin, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
Ordensklinikum Linz
Linz, Osterreich, Austria
Kepler University Hospital
Linz, Upper Austria, Austria
Medical University Vienna
Vienna, , Austria
Klinikum Wels-Grieskirchen
Wels, , Austria
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium
Az Delta
Roeselare, West Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur
Yvoir, , Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, , Brazil
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia
Fakultni Nemocnice Brno
Brno, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Institut Paoli-Calmettes
Marseille, Bouches Du Rhone, France
CHU de Rennes
Rennes, Brittany Region, France
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, France
Centre Francois Magendie
Pessac, Gironde, France
Hopital Saint Vincent-de-Paul
Lille, Nord, France
Centre Henri Becquerel
Rouen, Normandy, France
Nantes University Hospital
Nantes, Pays de la Loire Region, France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France
Centre Hospitalier d'Avignon
Avignon, , France
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, , France
Hopital Saint Louis
Paris, , France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, , France
Institut Curie
Saint-Cloud, , France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France
Avicenne Hospital
Bobigny, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Stauferklinikum
Mutlangen, Baden-Wurttemberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
LMU Klinikum
Munich, Bavaria, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
Stadtisches Krankenhaus Kiel
Kiel, , Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, , Germany
Assuta Ashdod Medical Center
Ashdod, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Assuta Medical Centers
Tel Aviv, , Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, Italy
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, Italy
S Gerardo Hospital
Monza, Monza E Brianza, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Aviano, Pordenone, Italy
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, Italy
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
A.O.U. di Modena
Modena, , Italy
Federico II University
Napoli, , Italy
AOU Maggiore della Carita
Novara, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera di Perugia
Perugia, , Italy
Ospedale Santa Maria delle Croci
Ravenna, , Italy
Santa Maria della Misericordia
Udine, , Italy
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru, Johor, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Hospital Ampang
Ampang, Selangor, Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor, Malaysia
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych Terapii
Lublin, Lublin Voivodeship, Poland
Pratia MCM Krakow
Krakow, Malopolska, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Pratia Poznan Medical Center
Poznan, Wielkopolska, Poland
Aidport
Skorzewo, Wielkopolska, Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, , Poland
Narodowy Instytut Onkologii - Clinical Study Location -
Warsaw, , Poland
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-Gu, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Yeyungnam University Medical Center
Daegu, , South Korea
Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Yeouido St. Marys Hospital
Seoul, , South Korea
Seoul St Marys Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Son Espases University Hospital
Palma, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Virgen De Las Nieves De Granada
Granada, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Fundacion Jimenez Diaz University Hospital
Madrid, , Spain
Hospital Universitario12 de Octubre
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
University Hospital Virgen del Rocio
Seville, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
University Hospital Doctor Peset
Valencia, , Spain
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Show Chwan Memorial Hospital
Changhua, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand
Sriraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Ankara University Faculty of Medicine
Mamak, Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, Turkey (Türkiye)
Gazi University
Ankara, Central Anatolia, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Istanbul University, Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Ege University
Izmir, , Turkey (Türkiye)
Dokuz Eylul University
Izmir, , Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, , Turkey (Türkiye)
Ondokuz Mayıs University
Samsun, , Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, , Turkey (Türkiye)
Royal Cornwall Hospital NHS Trust
Truro, Cornwall, United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, United Kingdom
University Hospitals Dorset
Bournemouth, Dorset, United Kingdom
Salisbury Foundation Trust
Salisbury, Hampshire, United Kingdom
The Hillingdon Hospital
Uxbridge, Middlesex, United Kingdom
James Paget University Hospitals Nhs Foundation Trust
Great Yarmouth, , United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, , United Kingdom
South Warwickshire NHS Foundation Trust
Warwick, , United Kingdom
Countries
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Central Contacts
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Related Links
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OLYMPIA
Other Identifiers
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2022-503092-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R1979-ONC-22102
Identifier Type: -
Identifier Source: org_study_id