Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

ClinicalTrials.gov ID: NCT06578247

Public ClinicalTrials.gov record NCT06578247. 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.

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ClinicalTrials.gov public records Last synced May 7, 2026, 2:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

Study identification

NCT ID: NCT06578247
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Daiichi Sankyo; Industry
Enrollment: 700 participants

Conditions and interventions

Conditions

Leukemia

Interventions

Chemotherapy Drug
Placebo Drug
Quizartinib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
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: Nov 18, 2024
Primary completion: Jun 25, 2030
Completion: Jun 25, 2030
Last update posted: Apr 29, 2026

2024 – 2030

United States locations

U.S. sites: 53
U.S. states: 27
U.S. cities: 47

Facility	City	State	ZIP	Site status
City of Hope Phoenix	Goodyear	Arizona	85338	Recruiting
Mayo Clinic - Phoenix	Phoenix	Arizona	85054	Recruiting
University of Arizona Cancer Center	Tucson	Arizona	85724	Recruiting
David Geffen School of Medicine	Los Angeles	California	90095	Recruiting
University of California Davis Health System	Sacramento	California	95817	Recruiting
Ucsf - School of Medicine	San Francisco	California	94115	Recruiting
Stanford University School of Medicine- Parent	Stanford	California	94305	Recruiting
Colorado Blood Cancer Institute	Denver	Colorado	80218	Recruiting
Yale University	New Haven	Connecticut	06510	Recruiting
Sibley Memorial Hospital	Washington D.C.	District of Columbia	20016	Recruiting
Mayo Clinic Hospital	Jacksonville	Florida	32224	Recruiting
Florida Hospital Cancer Institute - Kissimmee	Kissimmee	Florida	34741	Recruiting
Tampa General Hospital	Tampa	Florida	33606	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Winship Cancer Institute of Emory University	Atlanta	Georgia	30322	Recruiting
Augusta University	Augusta	Georgia	30912	Not yet recruiting
Robert H Lurie Comprehensive Cancer Center Northwestern University	Chicago	Illinois	60611	Recruiting
University of Illinois Hospital & Health Sciences System	Chicago	Illinois	60612	Recruiting
The University of Chicago Medical Center	Chicago	Illinois	60637	Recruiting
University of Kentucky	Lexington	Kentucky	40504	Recruiting
Ochsner Medical Center - New Orleans	New Orleans	Louisiana	70121	Not yet recruiting
Johns Hopkins Hospital	Baltimore	Maryland	21287	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
University of Michigan Comprehensive Cancer Center Michigan Medicine	Ann Arbor	Michigan	48109	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Recruiting
University of Minnesota Medical School - Twin Cities Campus	Minneapolis	Minnesota	55455	Recruiting
Mayo Clinic	Rochester	Minnesota	55902	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Not yet recruiting
Washington University	St Louis	Missouri	63110	Not yet recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Thomas Jefferson Univ Hosp	Haddonfield	New Jersey	08033	Recruiting
Roswell Park Comprehensive Cancer Center	Buffalo	New York	14263	Recruiting
Memorial Sloan Kettering Cancer Center - Main	Long Island City	New York	11101	Recruiting
Memorial Sloan Kettering Cancer Center - Main	New York	New York	10065	Not yet recruiting
Upstate University Hospital	Syracuse	New York	13210	Not yet recruiting
University of North Carolina Hospitals	Chapel Hill	North Carolina	27514	Recruiting
Duke Cancer Institute - Sarcoma Research	Durham	North Carolina	27710	Recruiting
University of Cincinnati	Cincinnati	Ohio	45219	Not yet recruiting
Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	44195	Recruiting
The James Cancer Hospital and Solove Research Institute	Columbus	Ohio	43210	Recruiting
Ohio Health Marion Area Physicians	Columbus	Ohio	43214	Recruiting
Peggy & Charles Stephenson Oklahoma Cancer Ctr	Oklahoma City	Oklahoma	73104	Recruiting
Oregon Health & Science University (Ohsu)	Portland	Oregon	97239	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
Upmc Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Not yet recruiting
Rhode Island Hospital	Providence	Rhode Island	02903	Recruiting
Tristar Bone Marrow Transplant	Nashville	Tennessee	37203	Recruiting
South Austin Medical Center	Austin	Texas	78745	Not yet recruiting
Houston Methodist Hospital	Houston	Texas	77030	Recruiting
The University of Texas Md Anderson Cancer Center	Houston	Texas	77030	Recruiting
Uva Health System	Charlottesville	Virginia	22908	Not yet recruiting
Virginia Commonwealth University (Vcu) Massey Cancer Center	Richmond	Virginia	23229	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

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 234 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06578247, 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 29, 2026 · Synced May 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06578247 live on ClinicalTrials.gov.

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