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Clinical trialNCT03813147CompletedPhase 1Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment12Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Myelodysplastic Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, fludarabine phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Children'S Hospital of Alabama

    Birmingham, Alabama, United States

  • Children'S Hospital of Orange County

    Orange, California, United States

  • Ucsf Medical Center-Mission Bay

    San Francisco, California, United States

  • Children'S Hospital Colorado

    Aurora, Colorado, United States

  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Children'S Healthcare of Atlanta - Egleston

    Atlanta, Georgia, United States

  • Lurie Children'S Hospital-Chicago

    Chicago, Illinois, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

  • C S Mott Children'S Hospital

    Ann Arbor, Michigan, United States

  • University of Minnesota/masonic Cancer Center

    Minneapolis, Minnesota, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • Nyp/columbia University Medical Center/herbert Irving Comprehensive Cancer Center

    New York, New York, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Children'S Hospital of Pittsburgh of Upmc

    Pittsburgh, Pennsylvania, United States

  • Saint Jude Children'S Research Hospital

    Memphis, Tennessee, United States

  • Baylor College of Medicine/dan L Duncan Comprehensive Cancer Center

    Houston, Texas, United States

  • Seattle Children'S Hospital

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
17 May 2019
Primary completion
30 Sept 2021
Completion
31 Dec 2023
Last update posted
13 Apr 2025
Registered enrollment
12
Registry id
NCT03813147

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.