Non Hodgkin Lymphoma Clinical Trial
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Summary
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"), have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory").
This study will be made up of Part 1a, Part 1b, and Part 2.The aim of Part 1a and Part 1b of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.
The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy, the current standard of care treatment approved for Non-Hodgkin's lymphoma (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 when combined with chemotherapy
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:
Previously untreated participants for lymphoma with documented cluster of differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL (Part 1A only)
Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy ≥ 12 months
International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only;
Adequate hematologic and organ function, as defined in the protocol.
KEY Exclusion Criteria:
Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
Another active malignancy, significant active disease or medical condition, as described in the protocol
Peripheral neuropathy Grade ≥3
Treatment with any systemic anti-lymphoma therapy
Any investigational therapy within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
Allergy/hypersensitivity to study drugs, as described in the protocol
Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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There are 86 Locations for this study
Orange California, 92868, United States
Indianapolis Indiana, 46202, United States
Noblesville Indiana, 46062, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
New Brunswick New Jersey, 08901, United States More Info
Principal Investigator
Stony Brook New York, 11794, United States
Westbury New York, 11590, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Houston Texas, 77030, United States
Ogden Utah, 84405, United States
Waukesha Wisconsin, 53188, United States More Info
Principal Investigator
Auchenflower Queensland, 4066, Australia
East Melbourne Victoria, 3121, Australia
Wels , 4600, Austria
Gent Oost-Vlaanderen, 9000, Belgium
Roeselare West Flanders, 8800, Belgium
Brussels , 1000, Belgium
Herentals , 2200, Belgium
Verviers , 4800, Belgium
Santiago Las Condes, 76201, Chile
Santiago Region Metropolitana, 75802, Chile
Santiago Región Metropolitana, 76505, Chile
Hradec Kralove 5 , 50005, Czechia
Praha , 12808, Czechia
Rennes Bretagne, 35033, France
Tours Centre Val De Loire, 37044, France
Bordeaux Cedex Gironde, 33077, France
Lille cedex Nord, 5900, France
Poitiers Nouvelle Aquitaine, 86000, France
Pessac Nouvelle-Aquitaine, F3360, France
Villejuif Paris, 94800, France
Chambery Savoie, 73000, France
Angers , 49933, France
Nimes , 30029, France
Paris , 75571, France
Saint-Etienne , 42055, France
Argenteuil Île De France, 95100, France
Dresden Sachsen, 01307, Germany
Meldola (fc) Forli-Cesena, 47014, Italy
Monza , 20900, Italy
Napoli , 80128, Italy
Novara , 28100, Italy
Ravenna , 48121, Italy
Suwon-si Gyeonggi-do, 16247, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49201, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 42415, Korea, Republic of
Daegu , 42601, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 6351, Korea, Republic of
Krakow Malopolskie, 30-51, Poland
Poznan Wielkopolska, 60185, Poland
Singapore , 30843, Singapore
Oviedo Asturias, 33011, Spain
Palma Balearic Islands, 07120, Spain
Sabadell Barcelona, 08208, Spain
Terrassa Barcelona, 08221, Spain
Santander Cantabria, 39008, Spain
Pozuelo de Alarcón Madrid, 28223, Spain
Barcelona , 08041, Spain
Granada , 18014, Spain
Madrid , 28031, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
Toledo , 45007, Spain
Valencia , 46009, Spain
Valencia , 46017, Spain
Bangkok Krung Thep Maha Nakhon [Bangko], 10330, Thailand
Bangkok , 10700, Thailand
Chiang Mai , 50200, Thailand
Khon Kaen , 40002, Thailand
Yenimahalle Ankara, 06200, Turkey More Info
Principal Investigator
Tekirdag Suleymanpasa, 59100, Turkey More Info
Principal Investigator
Besevler , 6500, Turkey
Istanbul , 34418, Turkey
Izmir , 35100, Turkey
Izmir , 35340, Turkey
Sakarya , 54290, Turkey More Info
Principal Investigator
Aberdeen , AB25 , United Kingdom
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