🏛️ Verified NIH Record • Updated 2026-06-17

Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission (NCT06824168)

A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Daiichi Sankyo

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

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Who can join: Review the eligibility criteria below.

Location: John Hopkins School of Medicine — Baltimore, Maryland

Age range: 18 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 (58 Sites)

Showing the first 25 of 58 sites.

  • John Hopkins School of Medicine — Baltimore, Maryland
  • Umass Memorial Health Care Systems — Worcester, Massachusetts
  • Roswell Park Cancer Institute — Buffalo, New York
  • Weill Cornell — New York, New York
  • Westchester Medical College — Valhalla, New York
  • Clinical Research Allicance — Westbury, New York
  • Spoknwrd Clinical Trials Inc. — Easton, Pennsylvania
  • The Methodist Hospital Research Institute — Houston, Texas
  • The University of Texas MD Anderson Cancer Center — Houston, Texas
  • Royal Adelaide Hospital — Adelaide,
  • Austin Health — Australia,
  • St. Vincent's Hospital Melbourne — Darlinghurst,
  • The Alfred Hospital — Melbourne,
  • Royal Perth Hospital — Perth,
  • Gold Coast University Hospital — Southport,
  • Westmead Hospital — Sydney,
  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer — Curitiba,
  • Cetus Hospital Dia Oncologia — Minas Gerai,
  • Hospital de Clínicas de Porto Alegre — Porto Alegre,
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa — Porto Alegre,
  • INCA - Instituto Nacional de Câncer — Rio de Janeiro,
  • "Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto CIP - Centro Integrado de Pesquisa" — San Jose Rio Preto,
  • Hospital Santa Marcelina — São Paulo,
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira — São Paulo,
  • Peking Union Medical College Hospital — Beijing,

📞 Contact the Study Coordinator

Phone: (908) 992-6400

Email: CTRinfo_us@daiichisankyo.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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. Contact the study coordinator using the phone/email above.
  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 ↗