Spots Global Cancer Trial Database for Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Official Title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
Study ID: NCT02668653
Study Description
Brief Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.
Detailed Description: This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Florida (UF) Health Shands Hospital, Gainesville, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Franciscan St. Francis Health Indianapolis, Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
NY Medical College - Hudson Valley Hematology Oncology Associates, Valhalla, New York, United States
Duke Clinical Research Institute, Durham, North Carolina, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
West Virginia University Hospitals, Inc., Morgantown, West Virginia, United States
Sanatorio Britanico, Rosario, Santa Fe, Argentina
Sanatorio Allende, Córdoba, , Argentina
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Townsville Hospital (TTH), Douglas, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
AZ Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
UCL Mont-Godinne, Yvoir, , Belgium
Hospital Amaral Carvalho, Brasília, , Brazil
Hospital do CEPON, Brasília, , Brazil
Instituto do Cancer do Estado de São Paulo, Brasília, , Brazil
Santa Casa de Misericórdia de Porto Alegre, Brasília, , Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo, , Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil
University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD, Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Sofia, , Bulgaria
Tom Baker Cancer Centre, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Vancouver General Hospital (VGH), Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Peking University First Hospital, Beijing, , China
The General Hospital of People's Liberation Army (301 Hospital), Beijing, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Guangdong General Hospital, Guangzhou, , China
Lanzhou University Second Hospital, Lanzhou, , China
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School, Shanghai, , China
West China Hospital, Sichuan University, Taiyuan, , China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Tang Du Hospital, Fourth Military Medical University, Xi'an, , China
Henan Cancer Hospital, Zhengzhou, , China
Klinička Bolnica Dubrava, Zagreb, , Croatia
Klinička Bolnica Merkur, Zagreb, , Croatia
Klinički Bolnički Centar Zagreb, Zagreb, , Croatia
Fakultní Nemocnice Hradec Králové, Hradec Kralove, , Czechia
Fakultní Nemocnice Olomouc, Olomouc, , Czechia
Fakultní Nemocnice Ostrava, Ostrava, , Czechia
Fakultni Nemocnice Plzen, Plzen, , Czechia
Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT), Praha 2, , Czechia
Hospital A. Michallon, Grenoble, , France
Centre Hospitalier de Versailles - Hôpital André Mignot, Le Chesnay, , France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille, , France
Centre Léon Bérard, Lyon, , France
L'Institut Paoli - Calmettes, Marguerittes, , France
Hôpital de la Conception, Marseille, , France
CHRU Montpellier - Saint Eloi, Montpellier, , France
Hôpital Saint-Antoine, Paris, , France
Hôpital Saint-Louis, Paris, , France
Hôpital Haut-Lévêque, Pessac, , France
Centre Hospitalier Lyon-Sud, Pierre Benite, , France
Centre Henri Becquerel - Centre de Lutte Contre le Cancer, Rouen, , France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan, Toulouse, , France
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Marien Hospital Düsseldorf GmbH, Düsseldorf, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt am Main, , Germany
Universitätsklinikum Halle (Saale), Halle, , Germany
Evangelisches Krankenhaus Hamm gGmbH, Hamm, , Germany
Medizinische Hochschule Hannover (MHH), Hannöver, , Germany
Universitätsklinikum Münster, Heidelberg, , Germany
Universitätsklinikum Tübingen, Heidelberg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Stauferklinikum Schwäbisch Gmünd, Mutlangen, , Germany
HELIOS Klinikum Wuppertal, Wuppertal, , Germany
Prince of Wales Hospital, Shatin, , Hong Kong
Markusovszky Egyetemi Oktatókórház, Budapest, , Hungary
Szegedi Tudományegyetem, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Pecsi Tudomanyegyetem Klinikai Központ, Pécs, , Hungary
Markusovszky Egyetemi Oktatókórház, Szombathely, , Hungary
Assaf Harofeh Medical Center, Be'er Ya'aqov, Tsifrin, Israel
Bnai Zion Medical Center, Haifa, , Israel
Rambam Medical Center, Haifa, , Israel
Hadassah University Medical Center, Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital, Petaẖ Tiqwa, , Israel
The Chaim Sheba Medical Center, Ramat-Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno, Ascoli Piceno, , Italy
Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari, Bari, , Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, , Italy
IRCCS AOU San Martino - IST, Genova, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
A.O.R.N. "A. Cardarelli", Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara, Novara, , Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, , Italy
Ospedale S. Maria delle Croci - Ravenna, Ravenna, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Ospedale S. Eugenio, Roma, , Italy
Policlinico Tor Vergata, Roma, , Italy
IRCCS Ospedale San Raffaele, Roma, , Italy
Azienda Ospedaliero-Universitaria Careggi, Roma, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara, Roma, , Italy
Azienda Ospedaliera Universitaria "Federico II", Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona, Salerno, , Italy
Azienda Ospedaliera Universitaria Senese, Siena, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette, Torino, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, , Italy
ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese, Varese, , Italy
National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan
Nagoya University Hospital, Nagoya, Aichi, Japan
Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan
Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan
University of Fukui Hospital, Yoshida, Fukui, Japan
Kyushu University Hospital, Higashi, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital, Maebashi, Gunma, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Chugoku Central Hospital, Fukuyama, Hiroshima, Japan
Sapporo Hokuyu Hospital, Sapporo, Hokkaido, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
National Hospital Organization Sendai Medical Center, Sendai, Miagi, Japan
Tenri Hospital, Tenri, Nara, Japan
Hamamatsu University Hospital, Hamamatsu, Shizuoka, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyō-Ku, Tokyo, Japan
The Jikei University Hospital, Minato-Ku, Tokyo, Japan
Akita University Hospital, Akita, , Japan
Aomori Prefectural Central Hospital, Aomori, , Japan
Chiba Aoba Municipal Hospital, Chiba, , Japan
Kameda Medical Center - Kameda General Hospital, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Gifu Municipal Hospital, Gifu, , Japan
National Hospital Organization Kagoshima Medical Center, Kagoshima, , Japan
Kobe City Medical Center General Hospital, Kobe, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto, , Japan
Nagasaki University Hospital, Nagasaki, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka Red Cross Hospital, Osaka, , Japan
NTT Medical Center Tokyo, Tokyo, , Japan
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
SoonChunHyang University Seoul Hospital, Seoul, , Korea, Republic of
Konkuk University Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, 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
Korea University Guro Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Sŏwŏn, , Korea, Republic of
Ulsan University Hospital (UUH), Ulsan, , Korea, Republic of
Szpital Uniwersytecki w Krakowie, Kraków, , Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Słupsk, , Poland
Instytut Hematologii i Transfuzjologi, Warszawa, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu, Warszawa, , Poland
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra, , Portugal
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos, Lisboa, , Portugal
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António, Porto, , Portugal
Instituto Português Oncologia do Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar de São João, EPE - Hospital de São João, Porto, , Portugal
Institutul Regional de Oncologie Iași, Bucuresti, , Romania
Spitalul Clinic Colentina, Bucuresti, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Spitalul Universitar de Urgenta Bucuresti, Bucuresti, , Romania
Institutul Clinic Fundeni, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca, Cluj-Napoca, , Romania
Spitalul Clinic Municipal Filantropia Craiova, Craiova, , Romania
Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005), Târgu-Mureş, , Romania
Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008), Târgu-Mureş, , Romania
Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, , Russian Federation
Penza Regional Oncology Dispensary, Penza, , Russian Federation
Republican Hospital n.a.V.A. Baranov, Petrozavodsk, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan', , Russian Federation
Almazov Federal North-West Medical Research Centre, Saint Petersburg, , Russian Federation
Saratov State Medical University named after V.I. Razumovsky, Saratov, , Russian Federation
Russian Research Institute of Hematology and Blood Transfusion, St. Petersburg, , Russian Federation
Leningrad Regional Clinic and Hospital, St. Petersburg, , Russian Federation
Tula Regional Clinical Hospital, Tula, , Russian Federation
Klinički Centar Srbije, Belgrade, , Serbia
Klinički Centar Niš, Nis, , Serbia
Klinički Centar Vojvodine, Novi Sad, , Serbia
National University Hospital (S) Pte Ltd, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospital Universitari Son Espases, Palma, Mallorca, Spain
Complejo Hospitalario Universitario de Albacete - Hospital General Universitario, Albacete, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Catalan Institute of Oncology (ICO), Badalona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial, Barcelona, , Spain
Hospital Duran i Reynals, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital Universitari de Girona Doctor Josep Trueta, Girona, , Spain
Complejo Hospitalario Universitario Granada, Granada, , Spain
Complexo Hospitalario Universitario A Coruña, La Coruña, , Spain
Hospital Dr. Negrín, Las Palmas De Gran Canaria, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Quirón Madrid, Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, , Spain
Hospital Regional Universitario de Málaga - Hospital General, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Fundación Jiménez Díaz, Pamplona, , Spain
Hospital Clínico Universitario "Lozano Blesa", Pamplona, , Spain
Hospital General Universitario Morales Meseguer, Pamplona, , Spain
Hospital Universitario Miguel Servet, Pamplona, , Spain
Hospital Álvaro Cunqueiro, Pamplona, , Spain
Hosp Universitario Salamanca, Salamanca, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario, Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari Joan XXIII de Tarragona, Tarragona, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Chang Gung Medical Foundation - Kaohsiung Branch, Kaohsiung, Niaosong District, Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou Branch, Taoyuan, , Taiwan
Cherkasy Regional Oncology Dispensary, Cherkasy, , Ukraine
Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho, Poltava, , Ukraine
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov, Vinnytsia, , Ukraine
Zhitomir Regional Clinical Hospital, Zhytomyr, , Ukraine
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital, Maidstone, , United Kingdom
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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