Non Hodgkin Lymphoma Clinical Trial
A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma
Summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients 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 the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide, (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 your 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 your quality-of-life and ability to complete routine daily activities
Eligibility Criteria
Key Inclusion Criteria:
Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator.
Must have refractory disease or relapsed after at least 2 cycles of prior systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-cluster of differentiation 20 (CD20) monoclonal antibody and patient should meet indication for treatment.
Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate hematologic and organ function.
Key Exclusion Criteria:
Primary central nervous system (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL.
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.
History of or current relevant CNS pathology, as described in the protocol.
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.
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.
Allergy/hypersensitivity to study drugs or excipients.
Active infection as defined in the protocol.
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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There are 65 Locations for this study
Indianapolis Indiana, 46202, United States
Stony Brook New York, 11794, United States
Westbury New York, 11590, United States
Waukesha Wisconsin, 84052, United States
Waratah New South Wales, 2298, Australia
East Melbourne Victoria, 3121, Australia
Gent Oost-Vlaanderen, 9000, Belgium
Brussels , 1000, Belgium
Yvoir , 5530, Belgium
Hradec Kralove 5 , 50005, Czechia
Paris Cedex 10, 75010, France
Tours Centre-Val De Loire, 37044, France
Bordeaux Cedex Gironde, 33077, France
Pessac Gironde, 33600, France
Bobigny Ile De France, 93000, France
Lille cedex Nord, 5900, France
Rouen Normandie, 76038, France
Chambery Savoie, 73000, France
Nantes , 44093, France
Paris , 75571, France
Rennes , 35033, France
Argenteuil Île De France, 95100, France
Meldola (fc) Forli-Cesena, 47014, Italy
Monza Monza E Brianza, 20900, Italy
Candiolo Torino, 10060, Italy
Genova , 16132, Italy
Napoli , 80128, Italy
Novara , 28100, Italy
Ravenna , 48121, Italy
Seongnam-si Gyeonggi-do, 13520, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 42415, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Suwon , 16247, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Johor Bahru Johor, 80100, Malaysia
Kota Kinabalu Sabah, 88586, Malaysia
Ampang Selangor, 68000, Malaysia
Krakow Malopolska, 30-51, Poland
Poznan Wielkopolska, 60185, Poland
Katowice , 40-51, Poland
Palma Balearic Islands, 07120, Spain
Santander Cantabria, 39008, Spain
Pozuelo de Alarcón Madrid, 28223, Spain
Barcelona , 08035, Spain
Granada , 18014, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Salamanca , 37007, Spain
Seville , 41013, Spain
Valencia , 46017, Spain
Taipei City , 10002, Taiwan
Taoyuan City , 333, Taiwan
Bangkok Krung Thep Maha Nakhon [Bangko], 10330, Thailand
Bangkok , 10700, Thailand
Chiang Mai , 50200, Thailand
Yenimahalle Ankara, 06200, Turkey
Tekirdag Suleymanpasa, 59100, Turkey
Ankara , 06100, Turkey
Izmir , 35340, Turkey
Sakarya , 54290, Turkey
Plymouth Devon, PL6 8, United Kingdom
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