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Completed Phase 3 Interventional Results available

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

ClinicalTrials.gov ID: NCT02668653

Public ClinicalTrials.gov record NCT02668653. 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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:15 AM 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, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

Study identification

NCT ID
NCT02668653
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
539 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 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
Sep 1, 2016 (Actual)
Primary completion
Aug 13, 2021 (Actual)
Completion
Jun 16, 2023 (Actual)
Last update posted
Aug 6, 2024

2016 – 2023

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
University of Florida (UF) Health Shands Hospital Gainesville Florida 90095 —
The University of Chicago Medical Center Chicago Illinois 60637 —
Franciscan St. Francis Health Indianapolis Indianapolis Indiana 46237 —
University of Kentucky Chandler Medical Center Lexington Kentucky 40536 —
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 —
NY Medical College - Hudson Valley Hematology Oncology Associates Valhalla New York 10595 —
Duke Clinical Research Institute Durham North Carolina 27710 —
University Hospitals Seidman Cancer Center Cleveland Ohio 44106 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
West Virginia University Hospitals, Inc. Morgantown West Virginia 26506 —

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 233 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02668653, 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 Aug 6, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02668653 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →