Spots Global Cancer Trial Database for Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
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Trial Identification
Brief Title: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Official Title: A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)
Study ID: NCT03768505
Interventions
Study Description
Brief Summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy
Detailed Description: This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncology Institute of Hope and Innovation, Tucson, Arizona, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Tower Hematology Oncology, Beverly Hills, California, United States
The Oncology Institute of Hope and Innovation, Downey, California, United States
Sharp Memorial Hospital, San Diego, California, United States
H. Lee Moffit Cancer Center, Tampa, Florida, United States
Cleveland Clinic-Florida, Weston, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Advocate Health & Hospitals Corporation, Niles, Illinois, United States
Investigative Clinical Research of Indiana LLC, Indianapolis, Indiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Medical School, Ann Arbor, Michigan, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
The Oncology Institute of Hope and Innovation, Henderson, Nevada, United States
Memorial Sloan Kettering, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering, Middletown, New Jersey, United States
Memorial Sloan Kettering, Montvale, New Jersey, United States
San Juan Oncology, Farmington, New Mexico, United States
Memorial Sloan Kettering, Commack, New York, United States
Memorial Sloan Kettering, Harrison, New York, United States
Clinical Research Alliance, Lake Success, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
Memorial Sloan Kettering, Uniondale, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Vanderbilt University, Nashville, Tennessee, United States
Renovatio Clinical, Houston, Texas, United States
Swedish Cancer Institute, Edmonds, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Medical Oncology Associates PS, Spokane, Washington, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Marshfield Medical Center, Marshfield, Wisconsin, United States
Peninsula and South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
The Perth Blood Institute, West Perth, Western Australia, Australia
Liverpool Hospital, Sydney, , Australia
Kepler Universitatsklinikum GmBH, Linz, , Austria
Medical University of Vienna, Vienna, , Austria
AZ Sint-Jan Brugge-Oostende, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Antwerp University Hospital, Edegem, , Belgium
C H de la Cote Basque, Service d'Hematologie, Bayonne, , France
CHD Vendee, Onco-hematologie, La Roche-Sur-Yon Cedex 9, , France
Centre Hospitalier du Mans, Le Mans, , France
Centre Hospitalier de Mulhouse, Mulhouse, , France
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie, Poitiers, , France
Institut Gustave Roussy, Villejuif, , France
Klinikum Mutterhaus Feldstr, Trier, Rheinland-Pfalz, Germany
Hamatologisch-Onkolgische Praxis, Nordheim, Stolberg, Germany
Universitatsklinikum Halle, Halle, , Germany
Munich Municipal Hospital, Munich, , Germany
Universitatsklinikum Munster, Münster, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, , Italy
Policlinico Sant'Orsola Malpighi, Bologna, , Italy
IRCCS AOU Policlinico San Martino, Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T., Meldola, , Italy
UOC Oncoematologia, Napoli, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
Infermi Hospital Rimini, Rimini, , Italy
Universita Cattolica del Sacro Cuore, Roma, , Italy
IRCCS Regina Elena National Cancer Institute, Rome, , Italy
Azienda Ospedaliera Santa Maria, Terni, , Italy
Ospedale DellAngelo Di Mestre Umberto I, Venice, , Italy
Dong-A University Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea-Seoul St. Marys Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
North Shore Hospital, Auckland, , New Zealand
Southern District Hospital, Dunedin, , New Zealand
Szpital Uniwersytecki nr 2 im., Bydgoszcz, , Poland
Pratia MCM Krakow, Kraków, , Poland
Primary Specialty Oncology, Warszawa, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw, , Poland
ojewodzkie Wielospecjalistyczne Centrum, Łódź, , Poland
Hospital Universitario de Canarias, La Laguna, Tenerife, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitari Mutua Terrasa, Barcelona, , Spain
ICO-Hospital Duran i Reynals, Barcelona, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Quiron Salud Madrid, Madrid, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Clinico de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Miguel Servet Hospital, Zaragoza, , Spain
Ente Ospedaliero Cantonale (EOC), Bellinzona, , Switzerland
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan City, , Taiwan
Chi-Mei Medical Center, Liouying, Tainan, , Taiwan
National Taiwan University Hospital NTUH, Taipei City, , Taiwan
North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Rhyl, Denbighire, United Kingdom
Royal Marsden Hospital, London, Sutton, United Kingdom
Nottingham University Hospital, Nottingham, UK, United Kingdom
Belfast Health and Social Care Trust - Belfast City Hospital, Belfast, , United Kingdom
Royal Cornwall Hospital, Cornwell, , United Kingdom
e Clatterbridge Cancer Centre, Liverpool, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
Lewisham and Greenwich University Hospital Lewisham, London, , United Kingdom
St George's Hospital, London, , United Kingdom
Centre for Haematology, Imperial College London, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, , United Kingdom
Oxford University Hospitals, Oxford, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Contact Details
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