Spots Global Cancer Trial Database for A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
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Trial Identification
Brief Title: A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Official Title: A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA
Study ID: NCT03416179
Conditions
Study Description
Brief Summary: Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
Detailed Description: Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated. Assignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations. Study B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML. Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Department of Medicine, Los Angeles, California, United States
UCLA Drug Information/Investigational Drugs, Los Angeles, California, United States
UCLA Hematology/Oncology Clinic, Los Angeles, California, United States
UCLA Ronald Reagan Medical Center, Los Angeles, California, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center, Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of California, San Francisco, San Francisco, California, United States
UCLA Hematology/Oncology - Westlake Village, Westlake Village, California, United States
Augusta University Medical Center, Augusta, Georgia, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Tufts Medical Center Investigational Drug Pharmacy, Boston, Massachusetts, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
MidAmerica Division, Inc., c/o Research Medical Center, Kansas City, Missouri, United States
Northwell Health/Monter Cancer Center, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
OHSU Center for Health and Healing, Portland, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
Centennial Medical Center, Nashville, Tennessee, United States
TriStar Bone Marrow Transplant, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Blood Cancer and Stem Cell Transplant Clinic, San Antonio, Texas, United States
Methodist Healthcare System of San Antonio, San Antonio, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Swedish Medical Center, Seattle, Washington, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
St George Hospital, Kogarah, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU, Salzburg, , Austria
Uniklinikum Salzburg, Landeskrankenhaus Salzburg, Salzburg, , Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Wien, , Austria
AZ Sint-Jan Brugge-Oostende av, Brugge, , Belgium
Universitaire Ziekenhuizen Brussel (UZ Brussel), Brussels, , Belgium
Universitaire Ziekenhuizen Brussel, Brussels, , Belgium
Universitaire Ziekenhuizen Leuven, Leuven, , Belgium
Health Sciences Centre, Winnipeg, Manitoba, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Royal University Hospital, Saskatoon, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China
Hebei Yanda Lu Daopei Hospital, Langfang, Hebei, China
Henan Provincial People's Hospital/Hematology Department, Zhengzhou, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center, Wuhan, Hubei, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
The First Affiliated Hospital College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, , China
Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno, Brno, , Czechia
Nemocnicni lekarna, Brno, , Czechia
Ustavni lekarna, Ostrava - Poruba, , Czechia
Klinika hematoonkologie, Ostrava-Poruba, , Czechia
Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady, Praha 10, , Czechia
Ústavni lékárna, Praha 10, , Czechia
CHU Henri Mondor, Créteil, , France
CHU de Nantes, Nantes cedex 1, , France
CHU de Nantes Hotel Dieu, Nantes cedex, , France
Hopital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud - Service d'Hematologie, Pierre-Benite cedex, , France
Institut Gustave Roussy, Villejuif cedex, , France
Klinikum der Universitaet Muenchen, Munich, Bavaria, Germany
Philipps-Universitaet Marburg, Marburg, Hesse, Germany
Universitätsklinikum Köln, Koeln, North Rhine Westphalia, Germany
Universitaetsklinikum Muenster, Muenster, North Rhine-westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek, Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Debrecen, , Hungary
Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály, Győr, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar, , Hungary
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia, Nyiregyhaza, , Hungary
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz,, Nyiregyhaza, , Hungary
Rambam Health Care Campus, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center (Ein Kerem), Jerusalem, , Israel
Hemato-oncology ambulatory Service, Petah Tikva, , Israel
Rabin Medical Center, Beilinson Hospital, Petah Tikva, , Israel
AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia, Torrette Di Ancona, Ancona, Italy
SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Torette Di Ancona, AN, Italy
A.O.U. di Ferrara- Arcispedale Sant'Anna,, Cona, Ferrara, FE, Italy
AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -, Pesaro, PU, Italy
Azienda Ospedaliera Universitaria Senese., Siena, SI, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria Senese, Siena, , Italy
Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi, Japan
University of Fukui Hospital, Yoshida-gun, Fukui, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Kobe University Hospital, Kobe-shi, Hyogo, Japan
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Osaka City University Hospital, Osaka-City, Osaka, Japan
Kindai University Hospital, Osaka-Sayama, Osaka, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
National Hospital Organization Disaster Medical Center, Tachikawa, Tokyo, Japan
Akita University Hospital, Akita, , Japan
Kyushu University Hospital, Fukuoka, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto, , Japan
Nagasaki University Hospital, Nagasaki, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Chonbuk National University Hospital, Jeonju-si, Jeollabuk-do, Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Clinical Trial Center, Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, 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
Instituto Nacional de Cancerología, México, MÉX, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo LEON, Mexico
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
WWCOiT im. M. Kopernika w Lodzi, Lodz, , Poland
Institutul Oncologic 'Prof. Dr. Ion Chiricuta', Cluj-Napoca, Cluj, Romania
Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie, Craiova, Dolj, Romania
Sp. Clinic de Urgenta Militar Central Dr. Carol Davila, Bucharest, , Romania
Spitalul Clinic Coltea, Clinica de Hematologie, Bucuresti, , Romania
State Budgetary Healthcare Institution of Moscow, Moscow, , Russian Federation
SBHI NNR NN RCH n. a. N.A. Semashko, Nizhniy Novgorod, , Russian Federation
State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH), Ryazan, , Russian Federation
V.A Almazov NMRC, Saint Petersburg, , Russian Federation
Hospital del Mar, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Arnau de Vilanova, Lleida, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Universitetssjukhuset Orebro, Orebro, , Sweden
Karolinska Universitetssjukhuset Huddinge, Stockholm, , Sweden
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Chang Gung Memorial Hospital-Linkou Branch, Taoyuan City, , Taiwan
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Birmingham, WEST Midlands, United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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