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NCT03793478 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia, sponsored by Daiichi Sankyo.

Active
Registry status
Phase 1
Development phase
65
Enrollment target
20
Study locations

NCT03793478 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 65 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT03793478, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Daiichi Sankyo.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
65 participants
Enrollment target
20
Study locations

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

Acute Myeloid Leukemia

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

236 total trials

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What the Registry Record Tells You About NCT03793478

The ClinicalTrials.gov registry entry for NCT03793478 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (44% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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.

NCT03793478 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Colorado.

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.

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).

Who is sponsoring clinical trial NCT03793478?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.