ClinicalTrials.gov record
Completed Phase 1 Interventional Results available

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

ClinicalTrials.gov ID: NCT03813147

Public ClinicalTrials.gov record NCT03813147. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 7:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924) Given in Combination With Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Study identification

NCT ID
NCT03813147
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
National Cancer Institute (NCI)
NIH
Enrollment
12 participants

Conditions and interventions

Interventions

  • Azacitidine Drug
  • Cytarabine Drug
  • Fludarabine Phosphate Drug
  • Methotrexate Drug
  • Pevonedistat Drug
  • Therapeutic Hydrocortisone Drug

Drug

Eligibility (public fields only)

Age range
1 Month to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 16, 2019
Primary completion
Sep 29, 2021
Completion
Dec 30, 2023
Last update posted
Apr 12, 2025

2019 – 2023

United States locations

U.S. sites
19
U.S. states
17
U.S. cities
19
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233
Children's Hospital of Orange County Orange California 92868
UCSF Medical Center-Mission Bay San Francisco California 94158
Children's Hospital Colorado Aurora Colorado 80045
Children's National Medical Center Washington D.C. District of Columbia 20010
Children's Healthcare of Atlanta - Egleston Atlanta Georgia 30322
Lurie Children's Hospital-Chicago Chicago Illinois 60611
Riley Hospital for Children Indianapolis Indiana 46202
Dana-Farber Cancer Institute Boston Massachusetts 02215
C S Mott Children's Hospital Ann Arbor Michigan 48109
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455
Washington University School of Medicine St Louis Missouri 63110
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224
Saint Jude Children's Research Hospital Memphis Tennessee 38105
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03813147, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2025 · Synced Apr 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03813147 live on ClinicalTrials.gov.

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