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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03416179




Registration number
NCT03416179
Ethics application status
Date submitted
21/12/2017
Date registered
31/01/2018
Date last updated
27/05/2020

Titles & IDs
Public title
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Scientific 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
Secondary ID [1] 0 0
2017-002822-19
Secondary ID [2] 0 0
B1371019
Universal Trial Number (UTN)
Trial acronym
BRIGHT AML1019
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - glasdegib
Treatment: Drugs - daunorubicin + cytarabine
Treatment: Drugs - azacitidine
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - glasdegib
Treatment: Drugs - cytarabine
Treatment: Surgery - HSCT

Experimental: Arm A (Intensive Study) - Glasdegib + '7+3' Induction(s)

Placebo Comparator: Arm B (Intensive Study) - Placebo + '7+3' Induction(s)

Experimental: Arm A (Non-intensive study) - Glasdegib + azacitidine

Placebo Comparator: Arm B (Non-intensive study) - Placebo + azacitidine


Treatment: Drugs: 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.

Treatment: Drugs: 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');

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Surgery: HSCT
If required, and done per standard of care post Induction(s).

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
5 years after last subject randomized
Secondary outcome [1] 0 0
Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire - Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.
Timepoint [1] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [2] 0 0
Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry) - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [2] 0 0
2 years after last dose of study therapy
Secondary outcome [3] 0 0
Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate) - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [3] 0 0
2 years after last dose of study therapy
Secondary outcome [4] 0 0
Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate) - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [4] 0 0
2 years after last dose of study therapy
Secondary outcome [5] 0 0
Event-free Survival
Timepoint [5] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [6] 0 0
Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS) - Measurement Scale from 0-10.
Timepoint [6] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [7] 0 0
Adverse events as graded by NCI CTCAE v4.03
Timepoint [7] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [8] 0 0
Laboratory abnormalities as graded by NCI CTCAE v4.03
Timepoint [8] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [9] 0 0
For the intensive study, the plasma trough concentration (Ctrough) will be analyzed
Timepoint [9] 0 0
PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)
Secondary outcome [10] 0 0
QTc interval
Timepoint [10] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [11] 0 0
PROs as measured by Patient Global Impression of Change (PGIC) - One question asking for description of leukemia symptoms.
Timepoint [11] 0 0
5 years after last patient randomized, withdrawal, or death
Secondary outcome [12] 0 0
Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L) - Series of questions that ask for information that best describes health.
Timepoint [12] 0 0
5 years after last subject randomized, withdrawal, or death
Secondary outcome [13] 0 0
Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS) - One question asking for information regarding leukemia symptoms.
Timepoint [13] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [14] 0 0
Complete Remission with incomplete hematologic recovery (CRi) - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [14] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [15] 0 0
Rate of morphological leukemia-free state (MLFS) - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [15] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [16] 0 0
Rate of Partial Remission (PR) - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [16] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [17] 0 0
Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only - Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.
Timepoint [17] 0 0
5 years after last subject randomized, consent withdrawal, or death
Secondary outcome [18] 0 0
Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study - Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.
Timepoint [18] 0 0
Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle
Secondary outcome [19] 0 0
Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study - It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.
Timepoint [19] 0 0
Cycle 1 Day 15 and Cycles 2 and 3 on Day 1

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Clinical Trials Pharmacy - Adelaide
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
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United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Austria
State/province [11] 0 0
Salzburg
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Brugge
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
Manitoba
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatchewan
Country [20] 0 0
China
State/province [20] 0 0
Anhui
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China
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Fujian
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China
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Guangdong
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China
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Hebei
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China
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Henan
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China
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Hubei
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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China
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Shanghai
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Czechia
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Brno
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Czechia
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Ostrava - Poruba
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Czechia
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Ostrava-Poruba
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Czechia
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Praha 10
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France
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Creteil
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France
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Créteil
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France
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Nantes cedex 1
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France
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Nantes cedex
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France
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Paris
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France
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Pierre Benite cedex
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France
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Villejuif cedex
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Germany
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Bavaria
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Germany
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Hesse
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Germany
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North Rhine Westphalia
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Germany
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North Rhine-westphalia
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Germany
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North-rhine-westphalia
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Germany
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Hamburg
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Germany
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Hannover
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Kaposvar
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Hungary
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Nyiregyhaza
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Italy
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Ancona
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Italy
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AN
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Italy
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FE
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Italy
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PU
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Italy
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SI
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Italy
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Bologna
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Italy
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Siena
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Japan
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Aichi
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Japan
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Fukui
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Japan
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Gunma
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Osaka
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Shizuoka
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Tokyo
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Japan
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Akita
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Japan
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Fukuoka
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Japan
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Kumamoto
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Japan
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Nagasaki
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Korea, Republic of
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Jeollabuk-do
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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MÉX
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Mexico
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Nuevo LEON
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Poland
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Gdansk
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Poland
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Lodz
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Bucuresti
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Spain
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Barcelona
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Orebro
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Sweden
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Solna
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Sweden
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Stockholm
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
State/province [102] 0 0
Surrey
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United Kingdom
State/province [103] 0 0
WEST Midlands
Country [104] 0 0
United Kingdom
State/province [104] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03416179
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03416179