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

Recruiting

Sponsor: Pfizer

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03416179

Protocol Info

Short Description: Glasdegib or Azacitidine in AML
Long Description: 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
MGH Status: Open
Sponsor: Pfizer
Disease Program: Leukemia

Next Steps


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Purpose

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).
Condition Title Intervention Phase
Leukemia, Myeloid, Acute glasdegib daunorubicin + cytarabine azacitidine Placebo Placebo glasdegib cytarabine HSCT Phase 3
Study Type Interventional
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

Primary Outcome Measures

Overall survival [Time Frame: 5 years after last subject randomized] [Designated as safety issue: ]


Secondary Outcome Measures

Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry) [Time Frame: 2 years after last dose of study therapy] [Designated as safety issue: ]

Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate) [Time Frame: 2 years after last dose of study therapy] [Designated as safety issue: ]

Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate) [Time Frame: 2 years after last dose of study therapy] [Designated as safety issue: ]

Event-free Survival [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS) [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Adverse events as graded by NCI CTCAE v4.03 [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Laboratory abnormalities as graded by NCI CTCAE v4.03 [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

For the intensive study, the plasma trough concentration (Ctrough) will be analyzed [Time Frame: 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)] [Designated as safety issue: ]

QTc interval [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

PROs as measured by Patient Global Impression of Change (PGIC) [Time Frame: 5 years after last patient randomized, withdrawal, or death] [Designated as safety issue: ]

Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L) [Time Frame: 5 years after last subject randomized, withdrawal, or death] [Designated as safety issue: ]

Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS) [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Complete Remission with incomplete hematologic recovery (CRi) [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Rate of morphological leukemia-free state (MLFS) [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Rate of Partial Remission (PR) [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only [Time Frame: 5 years after last subject randomized, consent withdrawal, or death] [Designated as safety issue: ]

Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study [Time Frame: Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle] [Designated as safety issue: ]

Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study [Time Frame: Cycle 1 Day 15 and Cycles 2 and 3 on Day 1] [Designated as safety issue: ]

Estimated Enrollment: 720
Study Start Date: April 2018
Estimated Study Completion Date: July 2025
Estimated Primary Completion Date: June 2021
Arms Assigned Interventions

Experimental:Arm A (Intensive Study)

Glasdegib + '7+3' Induction(s)
Procedure:HSCT
If required, and done per standard of care post Induction(s).

Placebo Comparator:Arm B (Intensive Study)

Placebo + '7+3' Induction(s)
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.

Experimental:Arm A (Non-intensive study)

Glasdegib + azacitidine
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.

Placebo Comparator:Arm B (Non-intensive study)

Placebo + azacitidine
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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03416179

Locations

  • United States, California
    • Keck Hospital of USC Los Angeles, California, United States, 90033
    • LAC+USC Medical Center Los Angeles, California, United States, 90033
    • USC/Norris Comprehensive Cancer Center / Investigational Drug Services Los Angeles, California, United States, 90033
    • USC/Norris Comprehensive Cancer Center Los Angeles, California, United States, 90033
    • Rrmc - UCLA Los Angeles, California, United States, 90095
    • UCLA Department of Medicine Los Angeles, California, United States, 90095
    • UCLA Hematology/Oncology Clinic Los Angeles, California, United States, 90095
    • UCLA Ronald Reagan Medical Center Los Angeles, California, United States, 90095
    • Keck Medicine of USC Norris Oncology/Hematology - Newport Beach Treatment Center Newport Beach, California, United States, 92663
    • USC Norris Oncology/Hematology - Newport Beach Newport Beach, California, United States, 92663
    • UC Irvine Health - Chao Family Comprehensive Cancer Center Orange, California, United States, 92868-3201
    • UC Irvine Medical Center Orange, California, United States, 92868-3201
    • UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California, United States, 94143
    • University of California, San Francisco Medical Center San Francisco, California, United States, 94143
    • University of California, San Francisco San Francisco, California, United States, 94143
  • United States, Massachusetts
    • Tufts Medical Center Investigational Pharmacy Boston, Massachusetts, United States, 02111
    • Tufts Medical Center Boston, Massachusetts, United States, 02111
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215
  • United States, Missouri
    • MidAmerica Division, Inc., c/o Research Medical Center Kansas City, Missouri, United States, 64132
  • United States, New York
    • Northwell Health/Monter Cancer Center Lake Success, New York, United States, 11042
    • North Shore University Hospital Manhasset, New York, United States, 11030
    • Long Island Jewish Medical Center New Hyde Park, New York, United States, 11040
    • University of Rochester Cancer Center Pharmacy Rochester, New York, United States, 14642
    • University of Rochester Medical Center Rochester, New York, United States, 14642
  • United States, Ohio
    • Taussig Cancer Center Investigational Pharmacy Cleveland, Ohio, United States, 44106
    • University Hospitals Cleveland Medical Center Cleveland, Ohio, United States, 44106
    • Cleveland Clinic Foundation Cleveland, Ohio, United States, 44195
  • United States, Tennessee
    • Centennial Medical Center Nashville, Tennessee, United States, 37203
    • The Sarah Cannon Research Institute Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Baylor Scott and White Research Institute Dallas, Texas, United States, 75246
    • Baylor University Medical Center Dallas, Texas, United States, 75246
    • The University of Texas, MD Anderson Cancer Center Houston, Texas, United States, 77030
    • Blood Cancer and Stem Cell Transplant Clinic San Antonio, Texas, United States, 78229
    • Methodist Healthcare System of San Antonio San Antonio, Texas, United States, 78229
    • Methodist Hospital Investigational Pharmacy San Antonio, Texas, United States, 78229
  • United States, Washington
    • Swedish Cancer Institute Seattle, Washington, United States, 98104
    • Swedish Investigational Drug Services Pharmacy Seattle, Washington, United States, 98104
    • Swedish Medical Center Seattle, Washington, United States, 98122
  • Australia, New South Wales
    • St Vincent's Hospital Sydney Darlinghurst, New South Wales, Australia, 2010
    • St George Hospital Kogarah, New South Wales, Australia, 2217
  • Australia, South Australia
    • Royal Adelaide Hospital - Clinical Trials Pharmacy Adelaide, South Australia, Australia, 5000
    • Royal Adelaide Hospital Adelaide, South Australia, Australia, 5000
  • Austria, Upper Austria
    • Klinikum Wels-Grieskirchen GmbH Wels, Upper Austria, Austria, 4600
  • Austria,
    • Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU Salzburg, , Austria, 5020
    • Uniklinikum Salzburg, Landeskrankenhaus Salzburg Salzburg, , Austria, 5020
    • Klinikum Wels-Grieskirchen GmbH Wels, , Austria, 4600
    • Sozialmedizinisches Zentrum Sud. Wien, , Austria, 1100
    • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel Wien, , Austria, 1130
  • Belgium,
    • AZ Sint-Jan Brugge - Oostende av Brugge, , Belgium, B-8000
    • AZ Sint-Jan Brugge-Oostende av Brugge, , Belgium, B-8000
    • Universitaire Ziekenhuizen Brussel (UZ Brussel) Brussels, , Belgium, B-1090
    • Universitaire Ziekenhuizen Brussel Brussels, , Belgium, B-1090
    • Universitaire Ziekenhuizen Leuven Leuven, , Belgium, B-3000
  • Canada, Manitoba
    • Health Sciences Centre Winnipeg, Manitoba, Canada, R3A 1R9
    • CancerCare Manitoba Winnipeg, Manitoba, Canada, R3E 0V9
  • Canada, Ontario
    • Sunnybrook Research Institute Toronto, Ontario, Canada, M4N 3M5
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont Montreal, Quebec, Canada, H1T 2M4
  • China, Guangdong
    • Guangdong Second Provincial General Hospital Guangzhou, Guangdong, China, 510317
  • China, Henan
    • Henan Cancer Hostipal Zhengzhou, Henan, China, 450008
  • China, Shandong
    • Affiliated Hospital of Qingdao University/Hematology Department Qingdao, Shandong, China, 266071
  • China, Shanghai
    • Shanghai General Hospital Shanghai, Shanghai, China, 200080
  • China, Sichuan
    • West China Hospital, Sichuan University Chengdu, Sichuan, China, 610041
  • China, Tianjin
    • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin, Tianjin, China, 300020
  • China, Zhejiang
    • The First Affiliated Hospital College of Medicine, Zhejiang University Hangzhou, Zhejiang, China, 310003
  • Czechia,
    • Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno Brno, , Czechia, 100 34
    • Nemocnicni lekarna Brno, , Czechia, 625 00
    • Ustavni lekarna Ostrava - Poruba, , Czechia, 708 52
    • Klinika hematoonkologie Ostrava-Poruba, , Czechia, 708 52
    • Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady Praha 10, , Czechia, 100 34
    • Ústavni lékárna Praha 10, , Czechia, 100 34
  • France,
    • CHU Henri Mondor Creteil, , France, 94010
    • CHU Henri Mondor Créteil, , France, 94010
    • CHU de Nantes Nantes cedex 1, , France, 44093
    • CHU de Nantes Hotel Dieu Nantes cedex, , France, 44093
    • Hopital Saint Louis Paris, , France, 75010
    • Centre Hospitalier Lyon Sud - Service d'Hematologie Pierre Benite cedex, , France, 69495
    • Centre Hospitalier Lyon Sud -Unite de Pharmacie Clinique Oncologique Pierre Benite cedex, , France, 69495
    • Institut Gustave Roussy Villejuif cedex, , France, 94805
  • Germany,
    • Medizinische Hochschule Hannover Hannover, , Germany, 30625
  • Hungary,
    • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek Debrecen, , Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika Debrecen, , Hungary, 4032
    • Petz Aladár Megyei Oktató Kórház, Gyógyszerészeti Osztály Győr, , Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály Győr, , Hungary, 9024
    • Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar, , Hungary, 7400
    • Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia Nyiregyhaza, , Hungary, 4400
    • Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Nyiregyhaza, , Hungary, 4400
  • Israel,
    • Shaare Zedek Medical Canter Jerusalem, , Israel, 9103102
    • Shaare Zedek Medical Center Jerusalem, , Israel, 9103102
    • Hadassah Medical Center (Ein Kerem) Jerusalem, , Israel, 91120
    • Hemato-oncology ambulatory Service Petah Tikva, , Israel, 4941492
    • Hematology Division - Oncology Pharmacy Petah Tikva, , Israel, 4941492
    • Rabin Medical Center, Beilinson Hospital Petah Tikva, , Israel, 4941492
  • Italy, Ancona
    • AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia Torrette Di Ancona, Ancona, Italy, 60126
  • Italy, AN
    • SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi Torette Di Ancona, AN, Italy, 60126
  • Italy, FE
    • A.O.U. di Ferrara- Arcispedale Sant'Anna, Cona, Ferrara, FE, Italy, 44124
    • Farmacia Ospedaliera Ferrara, FE, Italy, 44121
  • Italy, PU
    • AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro - Pesaro, PU, Italy, 61122
  • Italy, SI
    • Azienda Ospedaliera Universitaria Senese. Siena, SI, Italy, 53100
  • Italy,
    • Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi Bologna, , Italy, 40138
  • Japan, Aichi
    • Japanese Red Cross Nagoya Daini Hospital Nagoya, Aichi, Japan, 466-8650
  • Japan, Fukui
    • University of Fukui Hospital Yoshida-gun, Fukui, Japan, 910-1193
  • Japan, Gunma
    • Gunma University Hospital Maebashi, Gunma, Japan, 371-8511
  • Japan, Hyogo
    • Kobe University Hospital Kobe-shi, Hyogo, Japan, 650-0017
  • Japan, Kanagawa
    • Yokohama City University Medical Center Yokohama, Kanagawa, Japan, 232-0024
  • Japan, Miyagi
    • Tohoku University Hospital Sendai, Miyagi, Japan, 980-8574
  • Japan, Osaka
    • Osaka City University Hospital Osaka-City, Osaka, Japan, 545-8586
    • Kindai University Hospital Osaka-Sayama, Osaka, Japan, 589-8511
  • Japan, Shizuoka
    • Shizuoka Cancer Center Sunto-gun, Shizuoka, Japan, 411-8777
  • Japan, Tokyo
    • National Hospital Organization Disaster Medical Center Tachikawa, Tokyo, Japan, 190-0014
  • Japan,
    • Akita University Hospital Akita, , Japan, 010-8543
    • Kyushu University Hospital Fukuoka, , Japan, 812-8582
    • National Hospital Organization Kumamoto Medical Center Kumamoto, , Japan, 860-0008
    • Nagasaki University Hospital Nagasaki, , Japan, 852-8501
    • Tokyo Medical University Hospital Tokyo, , Japan, 160-0023
  • Korea, Republic of, Jeollabuk-do
    • Chonbuk National University Hospital Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
  • Korea, Republic of, Jeollanam-do
    • Chonnam National University Hwasun Hospital Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
  • Korea, Republic of,
    • Department of Pharmacy, Inje University Busan Paik Hospital Busan, , Korea, Republic of, 47392
    • Inje University Busan Paik Hospital Busan, , Korea, Republic of, 47392
    • Clinical trial Pharmacy, Keimyung University Dongsan Hospital Daegu, , Korea, Republic of, 42601
    • Keimyung University Dongsan Hospital Daegu, , Korea, Republic of, 42601
    • Gachon University Gil Medical Center Incheon, , Korea, Republic of, 21565
    • Seoul National University Hospital Seoul, , Korea, Republic of, 03080
    • Severance Hospital, Yonsei University Health System Seoul, , Korea, Republic of, 03722
    • Department of Pharmacy, Samsung Medical Center Seoul, , Korea, Republic of, 06351
    • Samsung Medical Center Seoul, , Korea, Republic of, 06351
    • The Catholic University of Korea Seoul St. Mary's Hospital Seoul, , Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, , Korea, Republic of, 06591
  • Mexico, MÉX
    • Instituto Nacional de Cancerología México, MÉX, Mexico, 14080
  • Mexico,
    • Hospital General de México Dr. Eduardo Liceaga México, , Mexico, 06726
  • Poland,
    • Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne Gdansk, , Poland, 80-214
    • WWCOiT im. M. Kopernika w Lodzi Lodz, , Poland, 93-513
  • Romania, Cluj
    • Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj-Napoca, Cluj, Romania, 400124
  • Romania, Dolj
    • Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie Craiova, Dolj, Romania, 200136
  • Romania,
    • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti Bucuresti, , Romania, 010825
    • Spitalul Clinic Coltea, Clinica de Hematologie Bucuresti, , Romania, 030171
  • Russian Federation,
    • SBHI CCH No. 40 HD Moscow Moscow, , Russian Federation, 129301
    • State Budgetary Healthcare Institution of Moscow Moscow, , Russian Federation, 129301
    • SBHI NNR NN RCH n. a. N.A. Semashko Nizhniy Novgorod, , Russian Federation, 603126
    • State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH) Ryazan, , Russian Federation, 390039
    • FSBI RusSRHTI FMBA of Russia Saint Petersburg, , Russian Federation, 191024
    • V.A Almazov NMRC Saint Petersburg, , Russian Federation, 197341
  • Spain,
    • Hospital del Mar Barcelona, , Spain, 08003
    • Hospital de la Santa Creu i Sant Pau Barcelona, , Spain, 08025
    • Hospital Universitario Arnau de Vilanova Lleida, , Spain, 25198
    • Hospital General Universitario Gregorio Maranon Madrid, , Spain, 28007
    • Hospital Universitario Ramon y Cajal Madrid, , Spain, 28034
    • Hospital Universitario Virgen del Rocio Sevilla, , Spain, 41013
    • Hospital Universitari i Politecnic La Fe Valencia, , Spain, 46026
  • Sweden,
    • Sektionen for hematologi och koagulation Goteborg, , Sweden, 413 45
    • APL, APL Sahlgrenska, Kliniska Provningar Goteborg, , Sweden, 413 46
    • ApoEx VN Orebro, , Sweden, 701 85
    • Universitetssjukhuset Orebro Orebro, , Sweden, 701 85
    • Karolinska Universitetssjukhuset Huddinge Stockholm, , Sweden, 141 86
  • Taiwan,
    • National Cheng Kung University Hospital Tainan, , Taiwan, 704
    • National Taiwan University Hospital Taipei, , Taiwan, 100
    • Department of Clinical Trial Pharmacy, Taipei Veterans General Hospital Taipei, , Taiwan, 11217
    • Taipei Veterans General Hospital Taipei, , Taiwan, 11217
    • Division of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center Taipei, , Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center Taipei, , Taiwan, 112
    • Chang Gung Memorial Hospital-Linkou Branch Taoyuan City, , Taiwan, 333
    • Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou Branch Taoyuan City, , Taiwan, 333
  • United Kingdom, Surrey
    • The Royal Marsden NHS Foundation Trust Sutton, Surrey, United Kingdom, SM2 5PT
  • United Kingdom, WEST Midlands
    • University Hospitals Birmingham NHS Foundation Trust Birmingham, WEST Midlands, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust Birmingham, WEST Midlands, United Kingdom, B30 3HG
  • United Kingdom,
    • Barts Health NHS Trust London, , United Kingdom, EC1A 7BE
    • Imperial College Healthcare NHS Trust London, , United Kingdom, W12 0HS

Sponsors and Collaborators

Pfizer

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03416179
Other Study ID Numbers: 2017-002822-19
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Pfizer:

glasdegib;

untreated;

Hedgehog Inhibitor

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Cytarabine

Azacitidine

Daunorubicin

Next Steps


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ClinicalTrials.gov processed this data on July 18, 2019