Spots Global Cancer Trial Database for Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
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Trial Identification
Brief Title: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Official Title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study
Study ID: NCT04745832
Study Description
Brief Summary: This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
Detailed Description: This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP). Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L). Approximately 534 randomized subjects will be enrolled in this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Oncology Institute of Hope and Innovation, Tucson, Arizona, United States
Orange Coast Memorial Medical Center, Fountain Valley, California, United States
Long Beach Memorial Medical Center, Long Beach, California, United States
The Oncology Institute of Hope and Innovation, Riverside, California, United States
BRCR Medical Center Inc, Hollywood, Florida, United States
Henry Ford Hospital, Detroit, Michigan, United States
Revive Research Institute, Farmington Hills, Michigan, United States
Revive Research Institute, Sterling Heights, Michigan, United States
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center, Springfield, Missouri, United States
Inspira Medical Center Mullica Hill, Mullica Hill, New Jersey, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Alpha Research Institute, LLC, Baytown, Texas, United States
Valley Cancer Associates, Harlingen, Texas, United States
Community Cancer Trials of Utah, Ogden, Utah, United States
Canberra Hospital, Garran, , Australia
The Perth Blood Institute (PBI), West Perth, , Australia
Westmead Hospital, Westmead, , Australia
AZ Sint-Jan Burgge-Oostende AV, Brugge, , Belgium
UZ Brussel, Brussel, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Center Hospitalier de Jolimont, Haine-Saint-Paul, , Belgium
UZ Leuven Campus Gasthuisberg, Leuven, , Belgium
Eastern Regional Health Authority, Saint John's, Newfoundland and Labrador, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie, Sherbrooke, Quebec, Canada
McGill University Health Centre, Québec, , Canada
CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,, Clermont-Ferrand, , France
Centre Hospitalier De Dunkerque - Service d'hématologie, Le Mans, , France
Centre Hospitalier du Mans, Le Mans, , France
Centre Leon Berard, Lyon, , France
Hôpital Saint-Louis, Paris, , France
CHU de Bordeaux - Maladies Du Sang, Centre François Magendie, Pessac, , France
Centre Henri Becquerel, Service d'Hematologie, Rouen, , France
CHU de Tours, Hôpital Bretonneau Centre, Tours Cedex 1, , France
Institut De Cancerologie Gustave Roussy, Villejuif, , France
LTD Israeli-Georgian Medical Research Clinic "Helsicore", Tbilisi, , Georgia
M. Zodelava Hematology Center, Tbilisi, , Georgia
J.S.C. K. Eristavi National Center of Experimental and Clinic, Tbilisi, , Georgia
LTD "Medinvest" Institute of Hematology and Transfusiology, Tbilisi, , Georgia
General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation, Athens, , Greece
University General Hospital of Ioannina, Department of Haematology, Ioánnina, , Greece
University General Hospital of Patras "Panagia H. Voitheia", Patras, , Greece
General Hospital of Thessaloniki "G. Papanikolaou", Thessaloníki, , Greece
Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Debrecen, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,, Nyiregyhaza, , Hungary
SOC Oncologia Medica e dei Tumori Immunocorrelati, Aviano, , Italy
UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi, Bologna, , Italy
U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle, Cuneo, , Italy
U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
U.O. Clinica Ematologica, Genova, , Italy
SC Oncologia Medica, Meldola, , Italy
UOC Ematologia, Presidio Ospedaliero Papardo, Messina, , Italy
UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre, Mestre, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milano, , Italy
Dipartimento di Oncoematologia, Unità Linfomi, Ospedale, Milano, , Italy
Divisione Oncoematologia, Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera Ospedali Riuniti Via Sofia, Palermo, , Italy
UO Ematologia, Ospedale Civile S.Maria delle Croci, Ravenna, , Italy
UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna, Rimini, , Italy
Istituti Fisioterapici Ospitalieri, Roma, , Italy
S.C. Oncoematologia Azienda Ospedaliera Santa Maria, Terni, , Italy
National Hospital Organization Nagoya Medical Center, Naka-ku, Aichi, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-Shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center, Minami, Fukuoka, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Kagoshima University Hospital, Sakuragaoka, Kagoshima-Shi, Kagoshima, Japan
University Hospital Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
Anjo Kosei Hospital, Aichi, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Aichi, , Japan
Aomori Prefectural Central Hospital, Aomori, , Japan
Chiba Cancer Center, Chiba, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Chugoku Central Hospital, Hiroshima, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
National University Corporation Tohoku University Hospital, Miyagi, , Japan
Aichi Cancer Center Hospital, Nagoya, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Osaka University Hospital, Osaka, , Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, , Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Tokyo, , Japan
Keio University Hospital, Tokyo, , Japan
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Dong-A university Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollyang, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul, , Korea, Republic of
Ewka Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Albert Schweizer Ziekenhuis, Hematology Department, Dordrecht, , Netherlands
Spaarne Gasthuis, Oncology Department, Hoofddorp, , Netherlands
Canterbury District Health Board, Haematology Department, Christchurch, , New Zealand
Dunedin Hospital, Southern Blood and Cancer Service, Dunedin, , New Zealand
Klinika Hematologii, Szpital Uniwersytecki, Bydgoszcz, , Poland
Pratia MCM Krakow, Kraków, , Poland
ARS Medical - Szpital, Oddzial hematologiczny, Piła, , Poland
Centrum Medyczne Pratia Poznan, Skorzewo, , Poland
University Clinical Center of Serbia, Clinic for Hematology, Belgrade, , Serbia
Zvezdara University Medical Center, Clinical department for Hematology and Oncology, Belgrade, , Serbia
Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology, Belgrade, , Serbia
Oncology Institute of Vojvodina, Clinic for Internal Oncology, Kamenica, , Serbia
University Clinical Center Kragujevac, Clinic for Hematology, Kragujevac, , Serbia
Clinical Center of Vojvodina, Clinic for Hematology, Novi Sad, , Serbia
Hospital Universitario Quironsalud, Alcorcón, Madrid, Spain
Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Hospital Universitario Mútua Terrassa, Barcelona, , Spain
Institut Catalá d'Oncologia, Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Complejo Hospitalario de Navarra, Navarro, , Spain
Hospital Universitario de Canarias, Santa Cruz De Tenerife, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Chi Mei Hospital, Tainan City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Gazi University Health Research and Application Hospital, Hematology Department, Ankara, , Turkey
Istanbul University Istanbul Medical Faculty, Hematology Department, Istanbul, , Turkey
Erciyes University Medical Faculty, Department of Hematology, Kayseri, , Turkey
Ondokuz Mayis University Medical Faculty, Hematology Department, Samsun, , Turkey
Namik Kemal University Hospital, Tekirdağ, , Turkey
Karadeniz Technical University Medical Faculty Department of Hematology, Trabzon, , Turkey
North Wales Cancer Treatment Centre, Bodelwyddan, Denbighshire, United Kingdom
Royal Cornwall Hospital, Cornwell, , United Kingdom
Department of Haematology St. George's University of London, London, , United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, London, , United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Genesis Care Oxford, Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust, Derriford Hopital, Plymouth, , United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, Surrey Quays, , United Kingdom
Contact Details
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