A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

NCT03416179

Last updated date
Study Location
Klinikum der Universitaet Muenchen
Munich, Bavaria, 81377, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, multi-center, placebo controlled study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind study.
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid, Acute
Intervention  ICMJE
  • Drug: 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.

    Other Name: PF-04449913
  • Drug: 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');

  • Drug: 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.
  • Drug: 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.

  • Drug: 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.
  • Drug: 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.

  • Drug: 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.
  • Procedure: HSCT
    If required, and done per standard of care post Induction(s).
Study Arms  ICMJE
  • Experimental: Arm A (Intensive Study)
    Glasdegib + '7+3' Induction(s)
    Interventions:
    • Drug: glasdegib
    • Drug: daunorubicin + cytarabine
    • Drug: cytarabine
    • Procedure: HSCT
  • Placebo Comparator: Arm B (Intensive Study)
    Placebo + '7+3' Induction(s)
    Interventions:
    • Drug: daunorubicin + cytarabine
    • Drug: Placebo
    • Drug: cytarabine
    • Procedure: HSCT
  • Experimental: Arm A (Non-intensive study)
    Glasdegib + azacitidine
    Interventions:
    • Drug: azacitidine
    • Drug: glasdegib
  • Placebo Comparator: Arm B (Non-intensive study)
    Placebo + azacitidine
    Interventions:
    • Drug: azacitidine
    • Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 12, 2025
Estimated Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   China,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Greece
 
Administrative Information
NCT Number  ICMJE NCT03416179
Other Study ID Numbers  ICMJE B1371019
2017-002822-19 ( EudraCT Number )
BRIGHT ( Other Identifier: Alias Study Number )
BRIGHT AML1019 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP