🏛️ Verified NIH Record • Updated 2026-03-26

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood (NCT03793478)

A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Daiichi Sankyo

🩺 Plain-English Summary (8th-Grade Level)

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.

Who can join: Review the eligibility criteria below.

Location: Loma Linda University Cancer Center — Loma Linda, California

Age range: 1 Month to 21 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

  • Loma Linda University Cancer Center — Loma Linda, California
  • University of California, San Francisco — San Francisco, California
  • Children's Hospital Colorado — Aurora, Colorado
  • A.I. duPont Hospital for Children — Wilmington, Delaware
  • Children's National Medical Center — Washington D.C., District of Columbia
  • Children's Healthcare of Atlanta — Atlanta, Georgia
  • University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
  • The University of Texas Southwestern Medical Center Children's Health — Dallas, Texas
  • Seattle Children's Hospital — Seattle, Washington
  • Universitair Ziekenhuis Gent — Ghent,
  • The Hospital for Sick Children — Toronto, Ontario
  • British Columbia Children's Hospital — Vancouver,
  • Rigshospitalet — Copenhagen,
  • Centre Léon Bérard — Lyon,
  • Hôpital Armand-Trousseau — Paris,
  • Hôpital des Enfants — Toulouse,
  • Rambam Medical Center — Haifa,
  • Tel Aviv Sourasky Medical Center — Tel Aviv,
  • Fondazione IRCCS San Gerardo dei Tintori — Monza,
  • IRCCS Ospedale Pediatrico Bambino Gesù — Rome,
  • Ospedale Infantile Regina Margherita — Torino,
  • Prinses Maxima Centrum voor Kinderoncologie — Utrecht,
  • Hospital Infantil Universitario Nino Jesus — Madrid,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗