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Recruiting Phase 3 NCT06149286

A Trial to Find Out 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

Phase 3 – large-scale trial before approval
Conditions: Relapsed/Refractory Follicular Lymphoma Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

Sponsor: Regeneron Pharmaceuticals

trial.available_in: БГ
Overview
This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). 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 well 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 relapsed/refractory 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
Who can participate
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 current or past histological evidence of 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 (inclusion diagnosis) 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
Locations 17
Australia (1)
Liverpool Hospital
Liverpool , New South Wales
Belgium (1)
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur
Yvoir , Namur
Brazil (1)
Hospital Sao Rafael
Salvador , Estado de Bahia
Czech Republic (1)
University Hospital Hradec Kralove
Hradec Králové , East Bohemia
France (1)
Institut Paoli-Calmettes
Marseille , Bouches Du Rhone
Germany (1)
Stauferklinikum
Mutlangen , Baden-Wurttemberg
Israel (1)
Assuta Ashdod Medical Center
Ashdod
ACTIVE_NOT_RECRUITING
Italy (1)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , Forli-Cesena
Malaysia (1)
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru , Johor
Poland (1)
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych , Lower Silesian Voivodeship
South Korea (1)
St. Vincents Hospital - The Catholic University of Korea
Suwon , Gyeonggi-do
Spain (1)
University Hospital of Santiago de Compostela
Santiago de Compostela , A Coruna
Taiwan (1)
Chang Gung Medical Foundation Chia Yi Branch
Buzi , Chiayi County
Thailand (1)
Chulalongkorn University
Bangkok , Krung Thep Maha Nakhon [Bangko]
Turkey (1)
Ankara University Faculty of Medicine
Mamak , Ankara
United Kingdom (1)
Royal Cornwall Hospitals NHS Trust
Truro , Cornwall
United States (1)
David Geffen School of Medicine at UCLA
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.12.2023
Completion date
23.01.2029
Registry ID
NCT06149286
Source
anzctr
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