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

NCT ID: NCT03416179

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2022-01-17

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).

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A (Intensive Study)

Glasdegib + '7+3' Induction(s)

Group Type: EXPERIMENTAL

glasdegib

Intervention Type: DRUG

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.

daunorubicin + cytarabine

Intervention Type: DRUG

'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');

cytarabine

Intervention Type: DRUG

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.

HSCT

Intervention Type: PROCEDURE

If required, and done per standard of care post Induction(s).

Arm B (Intensive Study)

Placebo + '7+3' Induction(s)

Group Type: PLACEBO_COMPARATOR

daunorubicin + cytarabine

Intervention Type: DRUG

'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');

Placebo

Intervention Type: DRUG

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.

cytarabine

Intervention Type: DRUG

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.

HSCT

Intervention Type: PROCEDURE

If required, and done per standard of care post Induction(s).

Arm A (Non-intensive study)

Glasdegib + azacitidine

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

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.

glasdegib

Intervention Type: DRUG

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.

Arm B (Non-intensive study)

Placebo + azacitidine

Group Type: PLACEBO_COMPARATOR

azacitidine

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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');

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

HSCT

If required, and done per standard of care post Induction(s).

Intervention Type: PROCEDURE

Other Intervention Names

PF-04449913

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

UCLA Department of Medicine

Los Angeles, California, United States

UCLA Drug Information/Investigational Drugs

Los Angeles, California, United States

UCLA Hematology/Oncology Clinic

Los Angeles, California, United States

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

UCLA Hematology/Oncology - Westlake Village

Westlake Village, California, United States

Augusta University Medical Center

Augusta, Georgia, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Tufts Medical Center Investigational Drug Pharmacy

Boston, Massachusetts, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

MidAmerica Division, Inc., c/o Research Medical Center

Kansas City, Missouri, United States

Northwell Health/Monter Cancer Center

Lake Success, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

OHSU Center for Health and Healing

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Centennial Medical Center

Nashville, Tennessee, United States

TriStar Bone Marrow Transplant

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Blood Cancer and Stem Cell Transplant Clinic

San Antonio, Texas, United States

Methodist Healthcare System of San Antonio

San Antonio, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

Salzburg, , Austria

Uniklinikum Salzburg, Landeskrankenhaus Salzburg

Salzburg, , Austria

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

Vienna, , Austria

AZ Sint-Jan Brugge-Oostende av

Bruges, , Belgium

Universitaire Ziekenhuizen Brussel (UZ Brussel)

Brussels, , Belgium

Universitaire Ziekenhuizen Brussel

Brussels, , Belgium

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Health Sciences Centre

Winnipeg, Manitoba, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

The First Affiliated Hospital of USTC, Anhui Provincial Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Hebei Yanda Lu Daopei Hospital

Langfang, Hebei, China

Henan Provincial People's Hospital/Hematology Department

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

Wuhan, Hubei, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno

Brno, , Czechia

Nemocnicni lekarna

Brno, , Czechia

Ustavni lekarna

Ostrava - Poruba, , Czechia

Klinika hematoonkologie

Ostrava-Poruba, , Czechia

Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady

Prague, , Czechia

Ústavni lékárna

Prague, , Czechia

CHU Henri Mondor

Créteil, , France

CHU de Nantes Hotel Dieu

Nantes, , France

CHU de Nantes

Nantes, , France

Hopital Saint Louis

Paris, , France

Centre Hospitalier Lyon Sud - Service d'Hematologie

Pierre-Bénite, , France

Institut Gustave Roussy

Villejuif, , France

Klinikum der Universitaet Muenchen

Munich, Bavaria, Germany

Philipps-Universitaet Marburg

Marburg, Hesse, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

Debrecen, , Hungary

Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika

Debrecen, , Hungary

Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály

Győr, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia

Nyíregyháza, , Hungary

Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz,

Nyíregyháza, , Hungary

Rambam Health Care Campus

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Medical Center (Ein Kerem)

Jerusalem, , Israel

Hemato-oncology ambulatory Service

Petah Tikva, , Israel

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

Torrette Di Ancona, Ancona, Italy

SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

Torette Di Ancona, AN, Italy

A.O.U. di Ferrara- Arcispedale Sant'Anna,

Cona, Ferrara, FE, Italy

AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -

Pesaro, PU, Italy

Azienda Ospedaliera Universitaria Senese.

Siena, SI, Italy

Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

University of Fukui Hospital

Yoshida-gun, Fukui, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Osaka City University Hospital

Osaka, Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Akita University Hospital

Akita, , Japan

Kyushu University Hospital

Fukuoka, , Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Tokyo Medical University Hospital

Tokyo, , Japan

Instituto Nacional de Cancerología

México, MÉX, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

WWCOiT im. M. Kopernika w Lodzi

Lodz, , Poland

Institutul Oncologic 'Prof. Dr. Ion Chiricuta'

Cluj-Napoca, Cluj, Romania

Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie

Craiova, Dolj, Romania

Sp. Clinic de Urgenta Militar Central Dr. Carol Davila

Bucharest, , Romania

Spitalul Clinic Coltea, Clinica de Hematologie

Bucharest, , Romania

State Budgetary Healthcare Institution of Moscow

Moscow, , Russia

SBHI NNR NN RCH n. a. N.A. Semashko

Nizhny Novgorod, , Russia

State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)

Ryazan, , Russia

V.A Almazov NMRC

Saint Petersburg, , Russia

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Inje University Busan Paik Hospital

Busan, , South Korea

Keimyung University Dongsan Hospital

Daegu, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Clinical Trial Center, Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Hospital del Mar

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Arnau de Vilanova

Lleida, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Universitetssjukhuset Orebro

Örebro, , Sweden

Karolinska Universitetssjukhuset Huddinge

Stockholm, , Sweden

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Chang Gung Memorial Hospital-Linkou Branch

Taoyuan, , Taiwan

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, WEST Midlands, United Kingdom

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; China; Czechia; France; Germany; Hungary; Israel; Italy; Japan; Mexico; Poland; Romania; Russia; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

Sekeres MA, Montesinos P, Novak J, Wang J, Jeyakumar D, Tomlinson B, Mayer J, Jou E, Robak T, Taussig DC, Dombret H, Merchant A, Shaik N, O'Brien T, Roh W, Liu X, Ma W, DiRienzo CG, Chan G, Cortes JE. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. Leukemia. 2023 Oct;37(10):2017-2026. doi: 10.1038/s41375-023-02001-z. Epub 2023 Aug 21.

Reference Type: DERIVED

PMID: 37604981 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31516032 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B1371019

To obtain contact information for a study center near you, click here.

Other Identifiers

2017-002822-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BRIGHT

Identifier Type: OTHER

Identifier Source: secondary_id

BRIGHT AML1019

Identifier Type: OTHER

Identifier Source: secondary_id

B1371019

Identifier Type: -

Identifier Source: org_study_id