Spots Global Cancer Trial Database for (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
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Trial Identification
Brief Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
Official Title: A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation
Study ID: NCT02039726
Conditions
Study Description
Brief Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
UC Davis Cancer Center, Sacramento, California, United States
Stanford University Medical Center Stanford Comprehensive Cancer Center, Stanford, California, United States
Yale University, New Haven, Connecticut, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
University of Illinois at Chicago, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Franciscan Alliance, Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute Inc, Westwood, Kansas, United States
LSU Health Sciences Center Feist Weiller Cancer Center, Shreveport, Louisiana, United States
University of Maryland, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
NY Medical College, Valhalla, New York, United States
UNC Linebreger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke Cancer Institute at Duke University Health System, Durham, North Carolina, United States
Wake Forest University Baptist Health, Winston-Salem, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Oregon Health and Science University Knight Cancer Institute, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
MD Anderson Center, The University of Texas, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
The Canbera Hospital, Garran, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
The Princess Alexandra Hospital, Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
The Queen Elizabeth Hospital, Woodville, South Australia, Australia
Alfred Hospital, Melbourne, Victoria, Australia
ZNA Stuivenberg, Antwerpen, BE, Belgium
UCL St Luc, Brussels, BE, Belgium
Leuven UZ Gasthuisberg, Leuven, BE, Belgium
University of Alberta Hospital, Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre Princess Margaret Hospital, Toronto, Ontario, Canada
KliniÄka Bolinca Merkur, Zagreb, , Croatia
KliniÄko BolniÄki Centar Zagreb, Zagreb, , Croatia
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec KrĂĄlovĂŠ, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
CHU de Caen, Caen, , France
Centre Hospitalier Universitaire Grenoble Hopital Michalon, Grenoble, , France
Centre Hospitalier de Versailles, Le Chesnay, , France
Hopital de la Conception, Marseille, , France
Centre Hospitalier Universitaire Nantes, Nantes, , France
HĂ´pital Saint Louis, Paris, , France
Hopital Saint-Antoine, Paris, , France
Hopital Haut Leveque Centre Francois Magendie, Pessac, , France
Centre Henri-Becquerel, Rouen, , France
Centre Hospitalier Universitaire Purpan, Toulouse, , France
CharitÊ Universitätsmedizin Berlin, Berlin, , Germany
CharitĂŠ Campus Virchow Klinikum, Berlin, , Germany
Klinikum Braunschweig, Braunschweig, , Germany
Universitatsklinikum Dresden, Dresden, , Germany
Klinikum der Johann Wolfgang-Goethe-Universität, Frankfurt, , Germany
Universitätsklinikum Halle, Halle, , Germany
Medizinische Hochschule Hannover, Hanover, , Germany
Uniklinik Heidelberg Medizinische Klinik und Poliklinik V, Heidelberg, , Germany
Universitätsklinikum Jena, Jena, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
University Mainz, Mainz, , Germany
Universitätsklinikum Giessen und Marburg GmbH, Marburg, , Germany
LMU MĂźnchen Klinikum GroĂhadern, Munchen, , Germany
Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie, Mßnster, , Germany
The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, , Hong Kong
The University of Hong Kong, Queen Mary Hospital, Hong Kong, , Hong Kong
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont, Szeged, Csongrad, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet, Debrecen, Hajdu Bihar, Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika, Budapest, Pest, Hungary
AOU Policlinico Consorziale di Bari, Bari, , Italy
UniversitĂ di Bologna, Bologna, , Italy
UnitĂ Operativa di Ematologia e UnitĂ Operativa CTMO, Cagliari, , Italy
Arcispedale S Anna, Ferrara, , Italy
AOU Careggi, Firenze, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Opsedale San Martino di Genova, Genova, , Italy
Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano, , Italy
L'UOC di Ematologia del Policlinico Tor Vergata, Rome, , Italy
Policlinico Universitario Agostino Gemelli, Rome, , Italy
Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte, Siena, , Italy
Ospedale di Circolo-a Fondazione Macchi, Varese, , Italy
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Seoul National University 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
Asan Medical Center, Seoul, , Korea, Republic of
VU Medisch Centrum, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn, Bialystok, , Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku, Katowice, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku, Lublin, , Poland
Klinicki Centar Srbije, Belgrade, , Serbia
Klinicki Centar Vojvodine, Novi Sad, , Serbia
National University of Singapore, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospital Son Espases, Palma, De Mallorca, Spain
Hospital La Fe, Valencia, SP, Spain
Hospital Clinic I Provincial de Barcelona, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
Hospital General Universitario Gregorio MaraĂąon, Madrid, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital ClĂnico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
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
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Saint James University Hospital, Leeds, England, United Kingdom
King's College Hospital, London, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Royal Marsden Hospital Sutton, Sutton, England, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
University Hospital of Wales, Cardiff, South Glamorgan, United Kingdom
Contact Details
Name: Jorge E. Cortes, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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