Clinical trialNCT01861002CompletedPhase 1Interventional

A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

SponsorTherapeutic Advances in Childhood Leukemia ConsortiumEnrollment15Lymphoblastic Leukemia, Acute, ChildhoodMyelogenous Leukemia, Acute, Childhood

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.

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Investigators

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

Weili Sun, MD, PhD
Children's Hospital Los Angeles
Study Chair
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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

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

Australia

Sydney Children'S Hospital
Randwick, New South Wales, Australia
Children'S Hospital at Westmead
Westmead, New South Wales, Australia

Canada

British Columbia Children'S Hospital
Vancouver, British Columbia, Canada
Sainte-Justine University Hospital Center
Montreal, Quebec, Canada

United States

Childrens Hospital Los Angeles
Los Angeles, California, United States
Ucsf School of Medicine
San Francisco, California, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Children'S Healthcare of Atlanta, Emory University
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber
Boston, Massachusetts, United States
C.S. Mott Children'S Hospital
Ann Arbor, Michigan, United States
Childrens Hospital & Clinics of Minnesota
Minneapolis, Minnesota, United States
Children'S Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Children'S Hospital New York-Presbyterian
New York, New York, United States
Levine Children'S Hospital at Carolinas Medical Center
Charlotte, North Carolina, United States
Rainbow Babies & Children'S Hospital
Cleveland, Ohio, United States
Nationwide Childrens Hospital
Columbus, Ohio, United States
Vanderbilt Children'S Hospital
Nashville, Tennessee, United States
University of Texas at Southwestern
Dallas, Texas, United States
Cook Children'S Medical Center
Fort Worth, Texas, United States
Primary Children'S Medical Center
Salt Lake City, Utah, United States
Seattle Children'S Hospital
Seattle, Washington, United States
Children'S Hospital of Wisconsin
Milwaukee, Wisconsin, 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.

Azacitidine →Cytarabine →Fludarabine →Intrathecal CytarabineIntrathecal Methotrexate

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: 22 May 2013
Primary completion: 28 Jul 2014
Completion: 28 Jul 2014
Last update posted: 9 Jun 2021
Registered enrollment: 15
Registry id: NCT01861002

clinicaltrials.gov ↗

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.