Non Hodgkin Lymphoma Clinical Trial
Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Summary
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:
In patients with follicular lymphoma (FL) grade 1-3a *1,2
In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
In patients with marginal zone lymphoma (MZL) *1
In patients with other B-NHL subtypes *1
Secondary objectives are:
To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
ORR according to the Lugano Classification and as assessed by local investigator evaluation
Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
Progression-free survival (PFS)*3
Overall survival (OS)
Duration of response (DOR)*3
Disease control rate (DCR)*3
To evaluate the safety and tolerability of odronextamab
To assess the pharmacokinetics (PK) of odronextamab
To assess the immunogenicity of odronextamab
To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)
1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
2 including an anti-CD20 antibody and an alkylating agent
3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation
Eligibility Criteria
Key Inclusion Criteria:
For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice
MZL cohort: New enrollment is paused until further notice
Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow, hepatic, and renal function as defined in the protocol
Key Exclusion Criteria:
Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
History of allogeneic stem cell transplantation
Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
Known hypersensitivity to both allopurinol and rasburicase
Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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There are 133 Locations for this study
Chicago Illinois, 60612, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40207, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02332, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07960, United States
New York New York, 10021, United States
Stony Brook New York, 11794, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73104, United States
Dallas Texas, 75390, United States
Fort Sam Houston Texas, 78234, United States
East Albury , NSW 2, Australia
East Melbourne , VIC 3, Australia
Frankston , VIC 3, Australia
Geelong , VIC 3, Australia
Heidelberg , VIC 3, Australia
Murdoch , NSW 2, Australia
Perth , 6000, Australia
Tweed Heads , VIC32, Australia
Edmonton Alberta, T6G17, Canada
Halifax Nova Scotia, B3H 2, Canada
Beijing Beijing, 10014, China
Guanngzhou City Guangdong, 15006, China
Zhengzhou City Henan, 45005, China
Chengdu Sichuan, 61004, China
Qiaokou District Wuhan Hubei Province, 43003, China
Hangzhou Zhejiang, 31005, China
Shangcheng District Hangzhou Zhejiang, 31000, China
Beijing City Beijing , 10019, China
Beijing City, Beijing , 10073, China
Chaoyang District Changchun , 13002, China
Gusu District Suzhou , 21503, China
HeXi District Tianjin City , 30006, China
Nangang District Harbin Heilongjiang , 15000, China
Shapingba District Chongqing , 40000, China
Tianjin City Tianjin , 30002, China
Wuhan Hubei Province , 43006, China
Xuhui District Shanghai , 20003, China
Yanta District Xi'an Shanxi , 71000, China
Caen , 14 00, France
Créteil , 94010, France
Lille , 59037, France
Nantes , 44093, France
Paris , 75013, France
Pessac , 33604, France
Pierre Bénite , 69310, France
Poitiers , 86021, France
Chemnitz , 09116, Germany
Halle , 06120, Germany
Mutlangen , 73557, Germany
Villingen-Schwenningen , 78052, Germany
Wurzburg , 97080, Germany
Bologna , 40138, Italy
Firenze , 50139, Italy
Livorno , 57124, Italy
Milano , 20122, Italy
Milano , 20162, Italy
Novara , 28100, Italy
Perugia , 06129, Italy
Ravenna , 48121, Italy
Reggio Emilia , 42123, Italy
San Giovanni Rotondo , 71013, Italy
Terni , 05100, Italy
Varese , 21100, Italy
Venice , 30174, Italy
Nagoya Aiti, 460-0, Japan
Nagoya Aiti, 466-8, Japan
Kashiwa-shi Chiba-ken, 277-8, Japan
Matsuyama Ehime, 791-0, Japan
Fukuoka-shi Hukuoka, 811-1, Japan
Kobe Hyōgo, 650-0, Japan
Kyoto City Kyoto, 602-8, Japan
Chuo ku , 104-0, Japan
Isehara-Shi , 259-1, Japan
L'Hospitalet De Llobregat , 350-1, Japan
Nagasaki , 852-8, Japan
Osaka City , 545-8, Japan
Tiba , 260-8, Japan
Yamagata City , 990-9, Japan
Busan , 49201, Korea, Republic of
Daegu-si , 41931, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 07985, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Gdańsk , 80-21, Poland
Gdynia , 81-51, Poland
Krakow , 30-51, Poland
Lodz , 93-51, Poland
Warszawa , 00-79, Poland
Warszawa , 02-78, Poland
Wrocław , 50-36, Poland
Singapore , 11907, Singapore
Singapore , 16960, Singapore
Singapore , 18877, Singapore
Singapore , 21756, Singapore
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Donostia , 20014, Spain
L'Hospitalet de llobregat , 08908, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Marbella , 29603, Spain
Palma de Mallorca , 07198, Spain
Palma , 07120, Spain
Salamanca , 37007, Spain
Valencia , 46026, Spain
Kaohsiung , 833, Taiwan
New Taipei City , 23561, Taiwan
Taichung City , 40447, Taiwan
Tainan City , 702, Taiwan
Tainan , 736, Taiwan
Taipei City , 10002, Taiwan
Taipei City , 10449, Taiwan
Taipei City , 11251, Taiwan
Taipei City , 114, Taiwan
Taoyuan , 333, Taiwan
Cardiff , CF14 , United Kingdom
Edinburgh , EH4 2, United Kingdom
London , SE5 9, United Kingdom
Plymouth , PL6 8, United Kingdom
Sutton , SM2 5, United Kingdom
Truro , TR1 3, United Kingdom
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