Clinical trialNCT05955261SuspendedPhase 2Interventional

A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

SponsorSt. Jude Children's Research HospitalEnrollment70Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). Primary Objectives: * Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML * Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: \- Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy

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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.

Hiroto Inaba, MD, PhD
St. Jude Children's Research Hospital
Principal Investigator
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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

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

United States

Valley Children'S Hospital
Madera, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Rady Children'S Hospital-San Diego
San Diego, California, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Ann & Robert H. Lurie Children'S Hospital
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
St. Jude Children'S Research Hospital
Memphis, Tennessee, United States
Cook Children'S Medical Center
Fort Worth, Texas, 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 →Daunorubicin →Etoposide →Fludarabine →Gemtuzumab ozogamicin →Gilteritinib →Idarubicin →Mitoxantrone →Venetoclax →

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: 25 Jul 2023
Primary completion: 31 Dec 2026
Completion: 31 Mar 2034
Last update posted: 28 Jul 2026
Registered enrollment: 70
Registry id: NCT05955261

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.