A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT03416179. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03416179
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 730 participants
Conditions and interventions
Conditions
Interventions
- glasdegib Drug
- daunorubicin + cytarabine Drug
- azacitidine Drug
- Placebo Drug
- cytarabine Drug
- HSCT Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 20, 2018 (Actual)
- Primary completion
- Jun 5, 2020 (Actual)
- Completion
- Jan 17, 2022 (Actual)
- Last update posted
- Apr 21, 2023
2018 – 2022
United States locations
- U.S. sites
- 30
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Department of Medicine | Los Angeles | California | 90095 | — |
| UCLA Drug Information/Investigational Drugs | Los Angeles | California | 90095 | — |
| UCLA Hematology/Oncology Clinic | Los Angeles | California | 90095 | — |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | — |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange | California | 92868-3201 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| UCLA Hematology/Oncology - Westlake Village | Westlake Village | California | 91361 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | — |
| Tufts Medical Center Investigational Drug Pharmacy | Boston | Massachusetts | 02111 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| MidAmerica Division, Inc., c/o Research Medical Center | Kansas City | Missouri | 64132 | — |
| Northwell Health/Monter Cancer Center | Lake Success | New York | 11042 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| TriStar Bone Marrow Transplant | Nashville | Tennessee | 37203 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Blood Cancer and Stem Cell Transplant Clinic | San Antonio | Texas | 78229 | — |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 119 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03416179, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03416179 live on ClinicalTrials.gov.