Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

ClinicalTrials.gov ID: NCT05183035

Public ClinicalTrials.gov record NCT05183035. 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.

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ClinicalTrials.gov public records Last synced May 8, 2026, 2:54 AM 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 Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Study identification

NCT ID: NCT05183035
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: PedAL BCU, LLC; Other
Enrollment: 130 participants

Conditions and interventions

Conditions

Acute Myeloid Leukemia

Interventions

Azacitidine Drug
Cytarabine Drug
Fludarabine Drug
Gemtuzumab Ozogamicin Drug
Venetoclax Drug

Drug

Eligibility (public fields only)

Age range: 29 Days 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: Sep 30, 2022
Primary completion: Jan 31, 2027
Completion: Mar 31, 2031
Last update posted: Apr 27, 2026

2022 – 2031

United States locations

U.S. sites: 44
U.S. states: 30
U.S. cities: 42

Facility	City	State	ZIP	Site status
Phoenix Children's Hospital	Phoenix	Arizona	85016	Recruiting
Arkansas Children's Hospital	Little Rock	Arkansas	72202	Recruiting
MemorialCare Miller Children's and Women's Hospital Long Beach	Long Beach	California	90806	Recruiting
Children's Hospital of Orange County Main Campus - Orange	Orange	California	92868	Recruiting
Benioff Children's Hospital - Mission Bay	San Francisco	California	94158	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Yale University	New Haven	Connecticut	06511	Recruiting
Nemours Alfred I. Dupont Hospital for Children	Wilmington	Delaware	19803	Recruiting
Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida	33908	Recruiting
University of Florida Health Shands Children's Hospital	Gainesville	Florida	32610	Recruiting
Nemours Children's Specialty Care Jacksonville	Jacksonville	Florida	32207	Recruiting
Nemours Children's Hospital - Orlando	Orlando	Florida	32827	Recruiting
Saint Joseph's Hospital - Tampa	Tampa	Florida	33607	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	30322	Recruiting
Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii	96826	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Comer Children's Hospital	Chicago	Illinois	60637	Recruiting
Indiana University School of Medicine	Indianapolis	Indiana	46202	Recruiting
University of Iowa Stead Family Children's Hospital	Iowa City	Iowa	52242	Recruiting
Norton Children's Hospital	Louisville	Kentucky	40202	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
C.S. Mott Children's Hospital	Ann Arbor	Michigan	48109-4259	Recruiting
Children's Hospital of Michigan	Detroit	Michigan	48201	Recruiting
Masonic Cancer Center	Minneapolis	Minnesota	55455	Recruiting
University of Mississippi Medical Center	Jackson	Mississippi	39216	Recruiting
The Children's Mercy Hospital - Adele Hall Campus	Kansas City	Missouri	64108	Recruiting
Washington University School of Medicine in St. Louis	St Louis	Missouri	63110	Recruiting
Alliance for Childhood Diseases dba Cure 4 The Kids Foundation	Las Vegas	Nevada	89135	Recruiting
Hackensack University Medical Center, HMH	Hackensack	New Jersey	07601	Recruiting
Morristown Medical Center	Morristown	New Jersey	07960	Recruiting
Columbia University Irving Medical Center	New York	New York	10032	Recruiting
Memorial Sloan Kettering Cancer Center - New York	New York	New York	10065	Recruiting
Cohen Children's Medical Center	Queens	New York	11040	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	43205	Recruiting
Doernbecher Children's Hospital	Portland	Oregon	97239	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Prisma Health Richland Hospital	Columbia	South Carolina	29203	Recruiting
St. Jude Children's Research Hospital	Memphis	Tennessee	38105-3678	Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	37232	Recruiting
Harold C. Simmons Comprehensive Cancer Center	Dallas	Texas	75235	Recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
Primary Children's Hospital	Salt Lake City	Utah	84113	Recruiting
Children's Hospital of Richmond at Virginia Commonwealth University	Richmond	Virginia	23219	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05183035, 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 27, 2026 · Synced May 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05183035 live on ClinicalTrials.gov.

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