417
Participants
Start Date
January 13, 2017
Primary Completion Date
March 31, 2020
Study Completion Date
November 30, 2020
Guadecitabine
Treatment Choice
"* BSC: according to standard/institutional practice; included RBC or platelet transfusions; growth factors, i.e. erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy; broad spectrum antibiotics and/or antifungals.~* LDAC: 20 mg/m\^2 SC or IV once daily (QD) for 14 days in 28-day cycles. Other schedules were allowed per institutional practice. Treatment for ≥4 cycles absent disease progression/toxicity. BSC per institutional/standard practice.~* Standard Intensive Chemotherapy: recommended regimen of 7+3 was given as cytarabine 100-200 mg/m\^2/day continuous infusion for 7 days and an anthracycline for 3 days. Anthracyclines per institutional practice included daunorubicin (45-60 mg/m\^2/day) or idarubicin (9-12 mg/m\^2/day) or mitoxantrone (8-12 mg/m\^2/day) by IV infusion. Participants with complete or partial response after IC induction received ≥1 additional cycles with reduced cytotoxic doses then BSC per standard /institutional practice."
Weill Cornell Medical College, New York
Stony Brook University Medical Center, Stony Brook
Roswell Park Cancer Institute, Buffalo
Penn State Milton S. Hershey Medical Center, Hershey
Fox Chase Cancer Center, Philadelphia
University of Maryland, Baltimore
West Virginia University Mary Babb Randolph Cancer Center, Morgantown
Duke Cancer Center, Durham
Medical University of South Carolina, Charleston
Bon Secours Saint Francis Hospital, Greenville
Cancer Specialists of North Florida, Fleming Island
Mount Sinai Medical Center, Miami Beach
Ulsan University Hospital, Ulsan
Franciscan Health Indianapolis, Indianapolis
University of Michigan Cancer Center, Ann Arbor
North Shore Medical Center, Evanston
Rush University Medical Center, Chicago
University of Texas MD Anderson Cancer Center, Houston
City of Hope, Duarte
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage
Swedish Cancer Institute, Seattle
Fred Hutchinson Cancer Research Center, Seattle
John Theurer Cancer Center, Hackensack
Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende, Bruges
Grand Hôpital de Charleroi - Notre Dame, Charleroi
Burnaby Hospital, Burnaby
Moncton Hospital, Moncton
Maisonneuve-Rosemont Hôpital Service d'Hematologie et d'Oncologie Medicale, Montreal
Saskatchewan Cancer Agency, Regina
Fakultní nemocnice Brno, Brno
Fakultni Nemocnice Hradec Králové, Hradec Králové
Fakultní nemocnice Ostrava, Ostrava
Fakultní Nemocnice Královské Vinohrady, Prague
Onkologická klinika Všeobecná fakultní nemocnice v Praze a 1, Prague
Aalborg Universitetshospital, Aalborg
Aarhus Universitetshospital, Aarhus
Rigshospitalet, Copenhagen
Odense University Hospital, Odense
Centre Hospitalier Universitaire, La Tronche
Hôpital Dupuytren, Limoges
GHR Mulhouse Sud-Alsace, Mulhouse
Hôpital Hôtel-Dieu, Nantes
Centre Antoine Lacassagne, Nice
Hôpital Saint Louis, Paris
Centre Hospitalier Lyon Sud, Pierre-Bénite
Centre Hospitalier Universitaire de Toulouse, Toulouse
Städtisches Klinikum Braunschweig, Braunschweig
Marien Hospital Düsseldorf, Düsseldorf
Universitaetsklinikum Freiburg, Freiburg im Breisgau
Universitätsklinikum Halle, Halle
Universitätsklinikum Ulm, Ulm
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria
Azienda Ospedaliero Universitaria Careggi, Florence
Azienda Ospedaliera Universitaria San Martino, Genova
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan
AORN A. Cardarelli, Napoli
Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara, Novara
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro
Ospedale S. Eugenio, Roma
NHO Nagoya Medical Center, Nagoya
Narita Red Cross Hospital, Narita
University of Fukui Hospital, Yoshida
Chugoku Central Hospital, Fukuyama-shi
Tokai University Hospital, Isehara
Kitasato University Hospital, Sagamihara-shi
Yokohama Municipal Citizen's Hospital, Yokohama
Nagasaki University Hospital, Nagasaki
Kansai Medical University Hirakata, Hirakata
Kindai University Hospital, Osakasayama-shi
Saitama Medical Center, Kawagoe
Nippon Medical School Hospital, Bunkyō-Ku
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto
NTT Medical Center Tokyo, Shinagawa
National Hospital Organization Disaster Medical Center, Tachikawa
National Hospital Organization Kyushu, Fukuoka
Fukushima Medical University, Fukushima
Gifu Municipal Hospital, Gifu
National Hospital Organization Kumamoto Medical Center, Kumamoto
Japanese Red Cross Kyoto Daini Hospital, Kyoto
University Hospital-Kyoto Prefectural University of Medicine, Kyoto
Yamagata University Hospital, Yamagata
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin
Instytut Hematologii i Transfuzjologii, Warsaw
Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw
Hospital General Universitario de Alicante, Alicante
Hospital Universitari Germans Trias i Pujol, Badalona
Fundació Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Hospital San Pedro de Alcantara, Cáceres
Hospital de León, León
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Ramón Y Cajal, Madrid
Hospital Universitario de Salamanca, Salamanca
Hospital Universitari i Politecnic La Fe de Valencia, Valencia
Sahlgrenska Universitetssjukhuset, Östra sjukhuset, Gothenburg
Universitetssjukhuset Örebro, Örebro
Medway NHS Foundation Trust, Gillingham
The Leeds Teaching Hospitals NHS Trust, Leeds
Chelsea and Westminster Hospital NHS Foundation Trust, London
Nottingham University Hospitals NHS Trust, Nottingham
Tom Baker Cancer Center, Calgary
University of Alberta Hospital, Edmonton
Royal Victoria Regional Health Centre, Barrie
Juravinski Cancer Centre, Hamilton
Princess Margaret Hospital, Toronto
Seoul National University Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Seoul Saint Mary's Hospital, Seoul
Lead Sponsor
Astex Pharmaceuticals, Inc.
INDUSTRY