Non Hodgkin Lymphoma Clinical Trial

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated

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

View Eligibility Criteria

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: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy.
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

512

Study ID:

NCT03888105

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 134 Locations for this study

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Rush University Medical Center
Chicago Illinois, 60612, United States
University of Iowa Hospital and Clinics
Iowa City Iowa, 52242, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Tufts Cancer Center
Boston Massachusetts, 02332, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
University/Academic Hospital Mayo Clinic
Rochester Minnesota, 55905, United States
SSM Saint Louis University Hospital
Saint Louis Missouri, 63110, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Weill Cornell Medical College
New York New York, 10021, United States
Stony Brook Hospital
Stony Brook New York, 11794, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Simmons Comprehensive Cancer Center
Dallas Texas, 75390, United States
Brook Army Medical Center
Fort Sam Houston Texas, 78234, United States
Border Medical Oncology, Albury Wodonga Regional Cancer Centre
East Albury , NSW 2, Australia
Epworth Hospital
East Melbourne , VIC 3, Australia
Penninsula & South Eastern Haemotology and Oncology Group
Frankston , VIC 3, Australia
Andrew Love Cancer Center
Geelong , VIC 3, Australia
Olivia Newton John Cancer Centre
Heidelberg , VIC 3, Australia
The Tweed Hospital
Murdoch , NSW 2, Australia
Royal Perth Hospital
Perth , 6000, Australia
Andrew Love Cancer Center
Tweed Heads , VIC32, Australia
Cross Cancer Center
Edmonton Alberta, T6G17, Canada
QEII Health Science Center
Halifax Nova Scotia, B3H 2, Canada
Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)
Beijing Beijing, 10014, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
The First Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21503, China
The First Bethune Hospital Of Jilin University
Changchun Jilin, 13002, China
West China Hospital of Sichuan University
Chengdu Sichuan, 61004, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan Wuhan Hubei Province, 43003, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou Zhejiang, 31005, China
Peking University Third Hospital
Beijing , 10019, China
Peking Union Medical College Hospital
Beijing , 10073, China
Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University)
Canton , 15006, China
Second Affiliated Hospital of Army Medical University, PLA
Chongqing , 40000, China
Harbin Medical University Cancer Hospital
Heilongjiang , 15000, China
Fudan University Cancer Hospital
Shanghai , 20003, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin , 30002, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin , 30006, China
Renmin Hospital of Wuhan University
Wuhan , 43006, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an , 71000, China
CHU de Caen
Caen , 14 00, France
Hospital Henri Mondor
Créteil , 94010, France
Hopital Huriez-CHRU Lille
Lille , 59037, France
CHU de Nantes
Nantes , 44093, France
Hospital Saint-Louis
Paris , 75010, France
Hopital de la Pitie Salpetriere
Paris , 75013, France
CHU Haut Leveque
Pessac , 33604, France
Centre Hospitalier Lyon Sud
Pierre Bénite , 69310, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers , 86021, France
Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin III
Chemnitz , 09116, Germany
University Hospital Halle Saale
Halle , 06120, Germany
Kliniken Ostalb, Stauferklinikum
Mutlangen , 73557, Germany
Klinik fur Innere Medizin II Schwarzwald Baar Klinikum
Villingen-Schwenningen , 78052, Germany
Universitätsklinikum Würzburg
Wurzburg , 97080, Germany
Policlinico Sant'Orsola Malpipghi
Bologna , 40138, Italy
Azienda Ospedaliera Careggi
Firenze , 50139, Italy
Ospedale Di Livorno Usl6
Livorno , 57124, Italy
Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
Milano , 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
AOU Maggiore della Carita
Novara , 28100, Italy
Santa Maria Della Misericordia Hospital
Perugia , 06129, Italy
Ospedale Santa Maria delle Croci
Ravenna , 48121, Italy
SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia , 42123, Italy
Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo , 71013, Italy
A.O. Santa Maria
Terni , 05100, Italy
Ospedale dell'Angelo
Varese , 21100, Italy
Ospedale DellAngelo Di Mestre Umberto I
Venice , 30174, Italy
National Hospital Organization Nagoya Medical Center
Nagoya Aiti, 460-0, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya Aiti, 466-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba-ken, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
National Hospital Organization National Kyushu Cancer Center
Fukuoka-shi Hukuoka, 811-1, Japan
Kobe City Medical Center General Hospital
Kobe Hyōgo, 650-0, Japan
" University Hospital Kyoto Prefectural University of Medicine"
Kyoto City Kyoto, 602-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
National Cancer Center Hospital
Chuo ku , 104-0, Japan
Tokai University Hospital
Isehara-Shi , 259-1, Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki , 852-8, Japan
Osaka Metropolitan University Hospital
Osaka City , 545-8, Japan
Saitama Medical University International Medical Center
Saitama , 350-1, Japan
Yamagata University Hospital
Yamagata City , 990-9, Japan
Dong-A University Hospital
Busan , 49201, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu-si , 41931, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul , 07985, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdańsk , 80-21, Poland
Szpitale Pomorskie spSp. Z.o.o.
Gdynia , 81-51, Poland
Małopolskie Centrum Medyczne S.C
Krakow , 30-51, Poland
Regeneron Study Site
Lodz , 93-51, Poland
Apteka IHiT (Instytut Hematologii I Transfuzjologii
Warszawa , 00-79, Poland
Instytut im. M. Sklodowskiej-Curie
Warszawa , 02-78, Poland
Uniwersytecki Szpital Kliniczny
Wrocław , 50-36, Poland
National University Hospital
Singapore , 11907, Singapore
Singapore General Hospital
Singapore , 16960, Singapore
Raffles Cancer Center
Singapore , 18877, Singapore
ICON-SOC Farrer Park Hospital
Singapore , 21756, Singapore
Hospital Universitario Vall De'Hebron
Barcelona , 08035, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona , 08041, Spain
Hospital Universitario Donostia
Donostia , 20014, Spain
Institut Català d'Oncologia
L'Hospitalet de llobregat , 08908, Spain
MD Anderson Cancer Center
Madrid , 28033, Spain
Fundacion Jimenez Diaz University Hospital
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Quiron Salud Madrid
Madrid , 28223, Spain
Hospital Costa del Sol
Marbella , 29603, Spain
Hospital son Llatzer
Palma de Mallorca , 07198, Spain
Hospital Son Espases
Palma , 07120, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain
Kaosiung Chang Gung Memorial Hospital
Kaohsiung , 833, Taiwan
Taipei Medical University - Shuang-Ho Hospital
New Taipei City , 23561, Taiwan
China Medical University Hospital
Taichung City , 40447, Taiwan
National Cheng Kung University Hospital
Tainan City , 702, Taiwan
Chi-Mei Medical Center-Liuying
Tainan , 736, Taiwan
National Taiwan University Hospital
Taipei City , 10002, Taiwan
Mackay Memorial Hospital
Taipei City , 10449, Taiwan
Koo Foundation Sun Yat Sen Cancer Center
Taipei City , 11251, Taiwan
Tri-Service General Hospital
Taipei City , 114, Taiwan
Chang Gung Memorial Hospital
Taoyuan , 333, Taiwan
University Hospital of Wales
Cardiff , CF14 , United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
Kings College Hospital
London , SE5 9, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
The Royal Marsden Hospital
Sutton , SM2 5, United Kingdom
Royal Cornwall Hospital
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

512

Study ID:

NCT03888105

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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