Spots Global Cancer Trial Database for 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
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: 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
Official Title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Study ID: NCT03888105
Conditions
Interventions
Study Description
Brief 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rush University Medical Center, Chicago, Illinois, United States
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Tufts Cancer Center, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
University/Academic Hospital Mayo Clinic, Rochester, Minnesota, United States
SSM Saint Louis University Hospital, Saint Louis, Missouri, United States
John Theurer Cancer Center Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Weill Cornell Medical College, New York, New York, United States
Stony Brook Hospital, Stony Brook, New York, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Simmons Comprehensive Cancer Center, Dallas, Texas, United States
Brook Army Medical Center, Fort Sam Houston, Texas, United States
Border Medical Oncology, Albury Wodonga Regional Cancer Centre, East Albury, , Australia
Epworth Hospital, East Melbourne, , Australia
Penninsula & South Eastern Haemotology and Oncology Group, Frankston, , Australia
Andrew Love Cancer Center, Geelong, , Australia
Olivia Newton John Cancer Centre, Heidelberg, , Australia
The Tweed Hospital, Murdoch, , Australia
Royal Perth Hospital, Perth, , Australia
Andrew Love Cancer Center, Tweed Heads, , Australia
Cross Cancer Center, Edmonton, Alberta, Canada
QEII Health Science Center, Halifax, Nova Scotia, Canada
Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research), Beijing, Beijing, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The First Bethune Hospital Of Jilin University, Changchun, Jilin, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Wuhan Hubei Province, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Peking University Third Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University), Canton, , China
Second Affiliated Hospital of Army Medical University, PLA, Chongqing, , China
Harbin Medical University Cancer Hospital, Heilongjiang, , China
Fudan University Cancer Hospital, Shanghai, , China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Renmin Hospital of Wuhan University, Wuhan, , China
The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, , China
CHU de Caen, Caen, , France
Hospital Henri Mondor, Créteil, , France
Hopital Huriez-CHRU Lille, Lille, , France
CHU de Nantes, Nantes, , France
Hospital Saint-Louis, Paris, , France
Hopital de la Pitie Salpetriere, Paris, , France
CHU Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, , France
Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin III, Chemnitz, , Germany
University Hospital Halle Saale, Halle, , Germany
Kliniken Ostalb, Stauferklinikum, Mutlangen, , Germany
Klinik fur Innere Medizin II Schwarzwald Baar Klinikum, Villingen-Schwenningen, , Germany
Universitätsklinikum Würzburg, Wurzburg, , Germany
Policlinico Sant'Orsola Malpipghi, Bologna, , Italy
Azienda Ospedaliera Careggi, Firenze, , Italy
Ospedale Di Livorno Usl6, Livorno, , Italy
Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
AOU Maggiore della Carita, Novara, , Italy
Santa Maria Della Misericordia Hospital, Perugia, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
A.O. Santa Maria, Terni, , Italy
Ospedale dell'Angelo, Varese, , Italy
Ospedale DellAngelo Di Mestre Umberto I, Venice, , Italy
National Hospital Organization Nagoya Medical Center, Nagoya, Aiti, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Aiti, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba-ken, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
National Hospital Organization National Kyushu Cancer Center, Fukuoka-shi, Hukuoka, Japan
Kobe City Medical Center General Hospital, Kobe, Hyōgo, Japan
" University Hospital Kyoto Prefectural University of Medicine", Kyoto City, Kyoto, Japan
Chiba Cancer Center, Chiba, , Japan
National Cancer Center Hospital, Chuo ku, , Japan
Tokai University Hospital, Isehara-Shi, , Japan
Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, , Japan
Osaka Metropolitan University Hospital, Osaka City, , Japan
Saitama Medical University International Medical Center, Saitama, , Japan
Yamagata University Hospital, Yamagata City, , Japan
Dong-A University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu-si, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Szpitale Pomorskie spSp. Z.o.o., Gdynia, , Poland
Małopolskie Centrum Medyczne S.C, Krakow, , Poland
Regeneron Study Site, Lodz, , Poland
Apteka IHiT (Instytut Hematologii I Transfuzjologii, Warszawa, , Poland
Instytut im. M. Sklodowskiej-Curie, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny, Wrocław, , Poland
National University Hospital, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Raffles Cancer Center, Singapore, , Singapore
ICON-SOC Farrer Park Hospital, Singapore, , Singapore
Hospital Universitario Vall De'Hebron, Barcelona, , Spain
Hospital Clinic I Provincial de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitario Donostia, Donostia, , Spain
Institut Català d'Oncologia, L'Hospitalet de llobregat, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Fundacion Jimenez Diaz University Hospital, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Quiron Salud Madrid, Madrid, , Spain
Hospital Costa del Sol, Marbella, , Spain
Hospital son Llatzer, Palma de Mallorca, , Spain
Hospital Son Espases, Palma, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Kaosiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Taipei Medical University - Shuang-Ho Hospital, New Taipei City, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
National Cheng Kung University Hospital, Tainan City, , Taiwan
Chi-Mei Medical Center-Liuying, Tainan, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Mackay Memorial Hospital, Taipei City, , Taiwan
Koo Foundation Sun Yat Sen Cancer Center, Taipei City, , Taiwan
Tri-Service General Hospital, Taipei City, , Taiwan
Chang Gung Memorial Hospital, Taoyuan, , Taiwan
University Hospital of Wales, Cardiff, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Kings College Hospital, London, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
