302
Participants
Start Date
March 16, 2017
Primary Completion Date
January 20, 2020
Study Completion Date
June 1, 2020
guadecitabine
In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. In Cycle 2, the guadecitabine dose will be 60 mg/m\^2 for either 10 days (Days 1-5 and 8-12) or 5 days (Days 1-5 only) based on assessment of disease response, and hematological recovery by Day ≥28.
Treatment Choice (TC)
"* High intensity: intermediate or high dose cytarabine (HiDAC); mitoxantrone, etoposide, and cytarabine (MEC); or fludarabine, cytarabine, G-CSF, +/- idarubicin (FLAG/FLAG-Ida).~* Low intensity: low dose cytarabine (LDAC), decitabine, or azacitidine.~* Best Supportive Care (BSC)."
SE ÁOK I. sz. Belgyógyászati Klinika, Budapest
Cliniques Universitaires Saint-Luc, Brussels
Rigshospitalet, Copenhagen
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Debreceni Egyetem Klinikai Központ, Debrecen
Universitätsklinikum Leipzig, Leipzig
Asan Medical Center, Seoul
Universitätsklinikum Halle (Saale), Halle
Samsung Medical Center, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Szegedi Tudományegyetem, Szeged
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár
AZ Sint-Jan Brugge-Oostende AV, Bruges
Aarhus University Hospital, Aarhus C
Hospital Clínic de Barcelona, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Duran i Reynals, Barcelona
Universitair Ziekenhuis Gent, Ghent
Hospital San Pedro de Alcántara, Cáceres
Weill Cornell Medical College, New York
Hôpital de la Conception, Marseille
Hospital Universitario Reina Sofía, Córdoba
Roswell Park Cancer Institute, Buffalo
IRCCS AOU San Martino - IST, Genova
Hospital of the University of Pennsylvania, Philadelphia
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan
Ospedale San Raffaele - Milano, Milan
Universitätsklinikum Schleswig-Holstein, Kiel
West Virginia University Hospitals, Inc., Morgantown
Duke Cancer Institute, Durham
Hospital General Universitario Gregorio Marañón, Madrid
Khmelnytskyi Regional Hospital, Khmelnytskyi
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse
Hospital Universitario Central de Asturias, Oviedo
A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia, Udine
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque, Pessac
CHRU Montpellier - Saint Eloi, Montpellier
Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho, Poltava
Vanderbilt University Medical Center, Nashville
Städtisches Klinikum Braunschweig gGmbH, Braunschweig
Marien Hospital Düsseldorf GmbH, Düsseldorf
Hospital Universitario Virgen del Rocío, Seville
Ulsan University Hospital (UUH), Ulsan
Hospital Universitario Dr. Peset, Valencia
Hospital Universitari i Politècnic La Fe, Valencia
Franciscan Research Center, Indianapolis
Pusan National University Hospital, Busan
The University of Chicago Medical Center, Chicago
Centre Hospitalier de la Côte Basque, Bayonne
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Mulhouse
Centre Hospitalier Lyon-Sud, Pierre-Bénite
Baylor Research Institute, Dallas
Hôpital Saint-Louis, Paris
Centre Henri Becquerel, Rouen
MD Anderson Cancer Center, Houston
"A.O.R.N. A. Cardarelli", Napoli
Klinikum der Universität München, München
University of New Mexico School of Medicine, Albuquerque
Universitätsklinikum Ulm, Ulm
University of Southern California, Los Angeles
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack
University of Oklahoma Medical Center, Oklahoma City
Temple University Hospital, Philadelphia
Tom Baker Cancer Centre, Calgary
University of Alberta Hospital, Edmonton
Princess Margaret Cancer Centre, Toronto
McGill University Health Centre, Montreal
Hopital Maisonneuve Rosemont, Montreal
Medizinischen Fakultät Mannheim der Universität Heidelberg, Mannheim
Pecsi Tudomanyegyetem Klinikai Központ, Pécs
Vall d'Hebron Institut d'Oncologia, Barcelona
Akita University Hospital, Akita
Chugoku Central Hospital, Fukuyama-Shi
Tokai University Hospital, Isehara-shi
Saitama Medical Center, Kawagoe-Shi
Kobe City Medical Center General Hospital, Kobe
Japanese Red Cross Kyoto Daini Hospital, Kyoto
University Hospital, Kyoto Prefectural University of Medicine, Kyoto
Gunmaken Saiseikai Maebashi Hospital, Maebashi
Nagasaki University Hospital, Nagasaki
The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki
Kindai University Hospital, Osakasayama-Shi
Saga University Hospital, Saga
NTT Medical Center Tokyo, Shinagawa-Ku
Shizuoka Cancer Center, Shizuoka
National Hospital Organization Disaster Medical Center, Tachikawa-Shi
Yamagata University Hospital, Yamagata
University of Fukui Hospital, Yoshida-Gun
Instytut Hematologii i Transfuzjologi, Warsaw
Sahlgrenska University Hospital, Gothenburg
Heart of England NHS Foundation Trust - Heartlands Hospital, Birmingham
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre, Bristol
East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital, Canterbury
St. James's University Hospital, Leeds
Lead Sponsor
Astex Pharmaceuticals, Inc.
INDUSTRY