Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 1

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

NCT03793478 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Fludarabine
  • DRUG Etoposide
  • DRUG Cytarabine
  • DRUG Quizartinib
  • DRUG Intrathecal (IT) triple chemotherapy prophylaxis

Study Locations (20)

Other

  • Universitair Ziekenhuis Gent — Ghent
  • 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

California

  • Loma Linda University Cancer Center — Loma Linda
  • University of California, San Francisco — San Francisco

Colorado

  • Children's Hospital Colorado — Aurora

Delaware

  • A.I. duPont Hospital for Children — Wilmington

District of Columbia

  • Children's National Medical Center — Washington D.C.

Georgia

  • Children's Healthcare of Atlanta — Atlanta

Minnesota

  • University of Minnesota/Masonic Cancer Center — Minneapolis

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2018-08-15
Est. Completion 2027-05-01
Phase Phase 1

Sponsor

Daiichi Sankyo

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03793478

The ClinicalTrials.gov registry entry for NCT03793478 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Fludarabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03793478 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03793478 about?

NCT03793478 is a clinical study titled "Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood". 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.

What is the current status of trial NCT03793478?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2018-08-15. Estimated completion is 2027-05-01.

What conditions does trial NCT03793478 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03793478?

The interventions under investigation include: Fludarabine (DRUG), Etoposide (DRUG), Cytarabine (DRUG), Quizartinib (DRUG), Intrathecal (IT) triple chemotherapy prophylaxis (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03793478?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03793478 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial