Clinical trial NCT03416179: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Myeloid, Acute
Keywords: glasdegib;
untreated;
Hedgehog Inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, multi-center, placebo controlled study.
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):

1. Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with:

   * AML arising from MDS or another antecedent hematologic disease (AHD).
   * AML after previous cytotoxic therapy or radiation (secondary AML).
2. 18 years of age (In Japan, 20 years of age).
3. Adequate Organ Function as defined by the following:

   * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.
   * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).
   * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.
4. QTc interval 470 msec using the Fridericia correction (QTcF).
5. All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines.

   * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.
6. Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.
7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.
8. Female subjects of non childbearing potential must meet at least 1 of the following criteria:

   1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
   2. Have medically confirmed ovarian failure; or
   3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

   All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
9. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow \[BM\] assessments).

Exclusion Criteria:

Subjects with any of the following characteristics/conditions will not be included in the study:

1. Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).
2. AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.

   * Complex genetics may include t(9;22) cytogenetic translocation.
3. Subjects with known active CNS leukemia.
4. Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.
5. Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
6. Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.
7. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as \<50 bpms.
8. Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
9. Subjects with left ventricular ejection fraction (LVEF) \<50% are excluded from the Intensive Chemotherapy Study only.
10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.
12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
13. Concurrent administration of herbal preparations.
14. Major surgery or radiation within 4 weeks of starting study treatment.
15. Documented or suspected hypersensitivity to any one of the following:

    * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.
    * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.
16. Known active drug or alcohol abuse.
17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
18. Pregnant females or breastfeeding female subjects.
19. Known recent or active suicidal ideation or behavior.
20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Primary outcomes:
measure: Intensive Study: Overall Survival (OS)
timeFrame: Baseline up to 25 months
measure: Non-intensive Study: Overall Survival (OS)
timeFrame: Baseline up to 25 months
Secondary outcomes:
measure: Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire
timeFrame: Post-baseline up to Week 8
measure: Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12
timeFrame: Post-baseline up to Week 12
measure: Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Percentage of Participants With Partial Remission (PR)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Percentage of Participants With Partial Remission (PR)
timeFrame: Day 1 up to maximum of 3 years
measure: Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Duration of Response (DoRi)
timeFrame: From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years)
measure: Non-intensive Study: Duration of Response (DoRi) or (DoRh)
timeFrame: From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years)
measure: Non-intensive Study: Time to Response
timeFrame: From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years)
measure: Intensive Study: Event-free Survival (EFS)
timeFrame: From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years)
measure: Non-intensive Study: Event-free Survival (EFS)
timeFrame: From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years)
measure: Intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Participants Global Impression of Symptoms (PGIS)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Participants Global Impression of Symptoms (PGIS)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Participants Global Impression of Change (PGIC)
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Participants Global Impression of Change (PGIC)
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03
timeFrame: Day 1 up to maximum of 3 years
measure: Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib
timeFrame: Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr
measure: Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib
timeFrame: Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1
measure: Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval
timeFrame: Day 1 up to maximum of 2 years
measure: Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval
timeFrame: Day 1 up to maximum of 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Medicine
state: California
city: Los Angeles
country: United States
facility: UCLA Drug Information/Investigational Drugs
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan Medical Center
state: California
city: Orange
country: United States
facility: UC Irvine Health - Chao Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology/Oncology - Westlake Village
state: California
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Boston
country: United States
facility: Tufts Medical Center Investigational Drug Pharmacy
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: MidAmerica Division, Inc., c/o Research Medical Center
state: Missouri
city: Lake Success
country: United States
facility: Northwell Health/Monter Cancer Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: TriStar Bone Marrow Transplant
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: Blood Cancer and Stem Cell Transplant Clinic
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende av
city: Brussels
country: Belgium
facility: Universitaire Ziekenhuizen Brussel (UZ Brussel)
city: Brussels
country: Belgium
facility: Universitaire Ziekenhuizen Brussel
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC, Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Langfang
country: China
facility: Hebei Yanda Lu Daopei Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital/Hematology Department
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
state: Hubei
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital College of Medicine, Zhejiang University
state: Zhejiang
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Brno
country: Czechia
facility: Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno
city: Brno
country: Czechia
facility: Nemocnicni lekarna
city: Ostrava - Poruba
country: Czechia
facility: Ustavni lekarna
city: Ostrava-Poruba
country: Czechia
facility: Klinika hematoonkologie
city: Praha 10
country: Czechia
facility: Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady
city: Praha 10
country: Czechia
facility: Ústavni lékárna
city: Créteil
country: France
facility: CHU Henri Mondor
city: Nantes cedex 1
country: France
facility: CHU de Nantes
city: Nantes cedex
country: France
facility: CHU de Nantes Hotel Dieu
city: Paris
country: France
facility: Hopital Saint Louis
city: Pierre-Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud - Service d'Hematologie
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen
state: Bavaria
city: Marburg
country: Germany
facility: Philipps-Universitaet Marburg
state: Hesse
city: Koeln
country: Germany
facility: Universitätsklinikum Köln
state: North Rhine Westphalia
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
state: North Rhine-westphalia
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz,
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center (Ein Kerem)
city: Petah Tikva
country: Israel
facility: Hemato-oncology ambulatory Service
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Torrette Di Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
state: Ancona
city: Torette Di Ancona
country: Italy
facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
state: AN
city: Cona, Ferrara
country: Italy
facility: A.O.U. di Ferrara- Arcispedale Sant'Anna,
state: FE
city: Pesaro
country: Italy
facility: AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -
state: PU
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese.
state: SI
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
state: Aichi
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka-City
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Osaka-Sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: México
country: Mexico
facility: Instituto Nacional de Cancerología
state: MÉX
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo LEON
city: Gdansk
country: Poland
facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
city: Lodz
country: Poland
facility: WWCOiT im. M. Kopernika w Lodzi
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic 'Prof. Dr. Ion Chiricuta'
state: Cluj
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie
state: Dolj
city: Bucharest
country: Romania
facility: Sp. Clinic de Urgenta Militar Central Dr. Carol Davila
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea, Clinica de Hematologie
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow
city: Nizhniy Novgorod
country: Russian Federation
facility: SBHI NNR NN RCH n. a. N.A. Semashko
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)
city: Saint Petersburg
country: Russian Federation
facility: V.A Almazov NMRC
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Orebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital-Linkou Branch
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: WEST Midlands
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13.