Non Hodgkin Lymphoma Clinical Trial
A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
Summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). 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
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the 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:
Diagnosis of cluster of differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
Need for treatment as described in the protocol
Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed tomography (CT) or Magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow function and hepatic function
Key Exclusion Criteria:
Central nervous system (CNS) lymphoma or leptomeningeal lymphoma
Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
Treatment with any systemic anti-lymphoma therapy
Infections and allergy/hypersensitivity to study drug or excipient
NOTE: Other protocol defined inclusion / exclusion criteria apply
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There are 50 Locations for this study
Orange California, 92868, United States
Noblesville Indiana, 46062, United States
New York New York, 10029, United States
Westbury New York, 11590, United States
Houston Texas, 77030, United States
Tyler Texas, 75701, United States
Charlottesville Virginia, 22908, United States
Waukesha Wisconsin, 53188, United States
Auchenflower Queensland, 4065, Australia
East Melbourne Victoria, 3002, Australia
Linz , 4020, Austria
Las Condes , 75802, Chile
Hradec Kralove 5 , 500 0, Czechia
Ashdod , 77476, Israel
Haifa , 31048, Israel
Jerusalem , 91120, Israel
Nahariya , 22100, Israel
Petah Tikva , 49100, Israel
Ramat-Gan , 52620, Israel
Candiolo , 10060, Italy
Genova , 16132, Italy
Meldola , 47014, Italy
Novara , 28100, Italy
Ravenna , 48121, Italy
Krakow Malopolskie, 30-51, Poland
Katowice , 40-51, Poland
Skorzewo , 60185, Poland
Granada , 18014, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Palma de Mallorca , 07120, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Pozuelo de Alarcon , 28223, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Sevilla , 41014, Spain
Taoyuan City Taoyuan County, 33305, Taiwan
Taipei , 100, Taiwan
Ankara , 06200, Turkey
Ankara , 06560, Turkey
Istanbul , 34093, Turkey
Istanbul , 34365, Turkey
Kayseri , 38039, Turkey
Sakarya , 54290, Turkey
Tekirdag , 59030, Turkey
Plymouth Devon, PL6 8, United Kingdom
Norwich Norfolk, NR4 7, United Kingdom
Truro , TR1 3, United Kingdom
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