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Clinical Trials in the UK / NCT06578247
Active, not recruiting Phase 3

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

NCT06578247 · tracked via the Priya Life Science UK tracker
Sponsor
Daiichi Sankyo
Phase
Phase 3
Started
2024-11-19
Last updated
2026-07-02

Condition(s) studied

Leukemia

Investigational drug(s) / intervention(s)

QuizartinibPlaceboChemotherapy

Quizartinib: Participants will receive quizartinib at 60 mg/day orally once daily

Placebo: Participants will receive placebo at 60 mg/day orally once daily

Chemotherapy: Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Study summary

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests. 2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening). 3. Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening) 4. Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2. 5. Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment Key Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy). 2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy. 3. Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others. 4. Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay. 5. Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy: 1. Leukapheresis; 2. Treatment for hyperleukocytosis with hydroxyurea; 3. Cranial radiotherapy for central nervous system (CNS) leukostasis; 4. Prophylactic intrathecal chemotherapy

Primary outcome measure(s)

Trial sites (284)

FacilityCityRegionStatus
City of Hope Phoenix Goodyear Arizona
Mayo Clinic - Phoenix Phoenix Arizona
University of Arizona Cancer Center Tucson Arizona
David Geffen School of Medicine Los Angeles California
University of California Davis Health System Sacramento California
Ucsf Helen Diller Family Comprehensive Cancer Center San Francisco California
Stanford University School of Medicine- Parent Stanford California
Colorado Blood Cancer Institute Denver Colorado
Yale University New Haven Connecticut
Sibley Memorial Hospital Washington D.C. District of Columbia
Mayo Clinic Hospital Jacksonville Florida
Florida Hospital Cancer Institute - Kissimmee Kissimmee Florida
Tampa General Hospital Tampa Florida
Moffitt Cancer Center Tampa Florida
Winship Cancer Institute of Emory University Atlanta Georgia
Augusta University Augusta Georgia
Robert H Lurie Comprehensive Cancer Center Northwestern University Chicago Illinois
University of Illinois Hospital & Health Sciences System Chicago Illinois
The University of Chicago Medical Center Chicago Illinois
University of Kentucky Lexington Kentucky
Ochsner Medical Center - New Orleans New Orleans Louisiana
Johns Hopkins Hospital Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
University of Michigan Comprehensive Cancer Center Michigan Medicine Ann Arbor Michigan
University of Minnesota Medical School - Twin Cities Campus Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Mayo Clinic Rochester Minnesota
Washington University St Louis Missouri
Hackensack University Medical Center Hackensack New Jersey
Thomas Jefferson Univ Hosp Haddonfield New Jersey
Roswell Park Comprehensive Cancer Center Buffalo New York
Memorial Sloan Kettering Cancer Center - Main Long Island City New York
Memorial Sloan Kettering Cancer Center - Main New York New York
Upstate University Hospital Syracuse New York
University of North Carolina Hospitals Chapel Hill North Carolina
Duke Cancer Institute - Sarcoma Research Durham North Carolina
University of Cincinnati Cincinnati Ohio
Cleveland Clinic Taussig Cancer Center Cleveland Ohio
The James Cancer Hospital and Solove Research Institute Columbus Ohio
Ohio Health Research Institute Columbus Ohio

+ 244 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06578247 on ClinicalTrials.gov ↗ ← All trials in the UK