730
Participants
Start Date
April 20, 2018
Primary Completion Date
June 5, 2020
Study Completion Date
January 17, 2022
glasdegib
"Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.~Following consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.~Daily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy."
daunorubicin + cytarabine
"'7+3' (cytarabine 100 mg/m2, IV for 7 days by continuous infusion and daunorubicin 60 mg/m2 for 3 days).~If a second induction is needed, Investigators may choose either a 5 day cytarabine continuous infusion plus daunorubicin for 2 days ('5+2') or a 7 day cytarabine continuous infusion plus daunorubicin for 3 days ('7+3');"
azacitidine
Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.
Placebo
"Matching placebo (PO) given on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, placebo will be administered daily for up to 2 years after randomization or until they have MRD negative disease, whichever comes first.~Daily placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy."
Placebo
Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.
glasdegib
"Glasdegib 100 mg PO QD is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment.~Subjects will continue glasdegib until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first."
cytarabine
Consolidation with single agent cytarabine 3 g/m2 IV for adults \<60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.
HSCT
If required, and done per standard of care post Induction(s).
National Taiwan University Hospital, Taipei
Koo Foundation Sun Yat-Sen Cancer Center, Taipei
Chang Gung Memorial Hospital-Linkou Branch, Taoyuan
National Cheng Kung University Hospital, Tainan City
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Vienna
St Vincent's Hospital Sydney, Darlinghurst
St George Hospital, Kogarah
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek, Debrecen
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Debrecen
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia, Nyíregyháza
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz,, Nyíregyháza
Royal Adelaide Hospital, Adelaide
Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU, Salzburg
Uniklinikum Salzburg, Landeskrankenhaus Salzburg, Salzburg
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár
Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály, Győr
North Shore University Hospital, Manhasset
Long Island Jewish Medical Center, New Hyde Park
Northwell Health/Monter Cancer Center, Lake Success
Taipei Veterans General Hospital, Taipei
Instituto Nacional de Cancerología, México
University of Rochester Medical Center, Rochester
Universitaetsklinikum Hamburg-Eppendorf, Hamburg
Gachon University Gil Medical Center, Incheon
Hospital Universitario Arnau de Vilanova, Lleida
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Medizinische Hochschule Hannover, Hanover
Augusta University Medical Center, Augusta
Georgia Cancer Center at Augusta University, Augusta
Philipps-Universitaet Marburg, Marburg
Centennial Medical Center, Nashville
TriStar Bone Marrow Transplant, Nashville
Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi, Bologna
Hospital Universitario Virgen del Rocio, Seville
Keimyung University Dongsan Hospital, Daegu
CHU de Nantes Hotel Dieu, Nantes
CHU de Nantes, Nantes
University Hospitals Cleveland Medical Center, Cleveland
A.O.U. di Ferrara- Arcispedale Sant'Anna,, Cona, Ferrara
Cleveland Clinic Foundation, Cleveland
Hospital Universitari i Politecnic La Fe, Valencia
Inje University Busan Paik Hospital, Busan
Universitaetsklinikum Muenster, Münster
Universitätsklinikum Köln, Cologne
Azienda Ospedaliera Universitaria Senese., Siena
Azienda Ospedaliera Universitaria Senese, Siena
Chonbuk National University Hospital, Jeonju
AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia, Torrette Di Ancona
SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Torette Di Ancona
AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -, Pesaro
MidAmerica Division, Inc., c/o Research Medical Center, Kansas City
"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey
Centre Hospitalier Lyon Sud - Service d'Hematologie, Pierre-Bénite
Hopital Saint Louis, Paris
Baylor University Medical Center, Dallas
Blood Cancer and Stem Cell Transplant Clinic, San Antonio
Methodist Healthcare System of San Antonio, San Antonio
Klinikum der Universitaet Muenchen, Munich
UCLA Department of Medicine, Los Angeles
UCLA Drug Information/Investigational Drugs, Los Angeles
UCLA Hematology/Oncology Clinic, Los Angeles
UCLA Ronald Reagan Medical Center, Los Angeles
Hadassah Medical Center (Ein Kerem), Jerusalem
UCLA Hematology/Oncology - Westlake Village, Westlake Village
CHU Henri Mondor, Créteil
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
University of California, San Francisco, San Francisco
Institut Gustave Roussy, Villejuif
OHSU Center for Health and Healing, Portland
Oregon Health & Science University, Portland
Swedish Cancer Institute, Seattle
Swedish Medical Center, Seattle
State Budgetary Healthcare Institution of Moscow, Moscow
V.A Almazov NMRC, Saint Petersburg
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai
Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie, Craiova
The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei
Anhui Provincial Hospital, Hefei
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin
The First Affiliated Hospital College of Medicine, Zhejiang University, Hangzhou
Fujian Medical University Union Hospital, Fuzhou
State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH), Ryazan
Institutul Oncologic 'Prof. Dr. Ion Chiricuta', Cluj-Napoca
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center, Wuhan
Henan Provincial People's Hospital/Hematology Department, Zhengzhou
Henan Cancer Hospital, Zhengzhou
Guangdong Provincial People's Hospital, Guangzhou
Guangdong Second Provincial General Hospital, Guangzhou
SBHI NNR NN RCH n. a. N.A. Semashko, Nizhny Novgorod
West China Hospital, Sichuan University, Chengdu
Rambam Health Care Campus, Haifa
Hemato-oncology ambulatory Service, Petah Tikva
Rabin Medical Center, Beilinson Hospital, Petah Tikva
Shaare Zedek Medical Center, Jerusalem
UC Irvine Health - Chao Family Comprehensive Cancer Center, Orange
Tufts Medical Center Investigational Drug Pharmacy, Boston
Tufts Medical Center, Boston
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
AZ Sint-Jan Brugge-Oostende av, Bruges
Universitaire Ziekenhuizen Brussel (UZ Brussel), Brussels
Universitaire Ziekenhuizen Brussel, Brussels
Universitaire Ziekenhuizen Leuven, Leuven
Health Sciences Centre, Winnipeg
CancerCare Manitoba, Winnipeg
Sunnybrook Research Institute, Toronto
Princess Margaret Cancer Centre, Toronto
CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont, Montreal
Royal University Hospital, Saskatoon
Saskatoon Cancer Centre, Saskatoon
Hebei Yanda Lu Daopei Hospital, Langfang
Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno, Brno
Nemocnicni lekarna, Brno
Ustavni lekarna, Ostrava - Poruba
Klinika hematoonkologie, Ostrava-Poruba
Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady, Prague
Ústavni lékárna, Prague
Japanese Red Cross Nagoya Daini Hospital, Nagoya
University of Fukui Hospital, Yoshida-gun
Gunma University Hospital, Maebashi
Kobe University Hospital, Kobe
Yokohama City University Medical Center, Yokohama
Tohoku University Hospital, Sendai
Osaka City University Hospital, Osaka
Kindai University Hospital, Ōsaka-sayama
Shizuoka Cancer Center, Sunto-gun
National Hospital Organization Disaster Medical Center, Tachikawa
Akita University Hospital, Akita
Kyushu University Hospital, Fukuoka
National Hospital Organization Kumamoto Medical Center, Kumamoto
Nagasaki University Hospital, Nagasaki
Tokyo Medical University Hospital, Tokyo
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne, Gdansk
WWCOiT im. M. Kopernika w Lodzi, Lodz
Sp. Clinic de Urgenta Militar Central Dr. Carol Davila, Bucharest
Spitalul Clinic Coltea, Clinica de Hematologie, Bucharest
Seoul National University Hospital, Seoul
Clinical Trial Center, Severance Hospital, Yonsei University Health System, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Samsung Medical Center, Seoul
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul
Hospital del Mar, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Universitetssjukhuset Orebro, Örebro
Karolinska Universitetssjukhuset Huddinge, Stockholm
The Royal Marsden NHS Foundation Trust, Sutton
University Hospitals Birmingham NHS Foundation Trust, Birmingham
Imperial College Healthcare NHS Trust, London
Lead Sponsor
Pfizer
INDUSTRY