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

NCT05955261 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-23

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Venetoclax

Venetoclax will be given with each course of therapy. Patients with low-risk AML will receive four courses of therapy, intermediate-risk patients will receive five courses of therapy, and high-risk patients will receive two or three courses of therapy followed by hematopoietic stem cell transplantation.

DRUG

Azacitidine

Given IV over 30 minutes on days 1-5

DRUG

Cytarabine

Given IV over 30 minutes q12 hours on days 1-8 (16 doses)

DRUG

Gemtuzumab Ozogamicin

Given IV

DRUG

Daunorubicin Hydrochloride

IV over 1 hour on days 1, 3, and 5

DRUG

Fludarabine Phosphate

Given IV over 30 minutes on days 1-5

DRUG

Idarubicin Hydrochloride

Given IV over 15 minutes on days 3-5

DRUG

Mitoxantrone Hydrochloride

IV over 1 hour on days 2-4

DRUG

Etoposide

Given IV over 1 hour on days 1-5

DRUG

Gilteritinib

PO on days 8-28 (21 doses)

Sponsors & Collaborators

Principal Investigators

  • Hiroto Inaba, MD, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2026-12-31
Completion
2034-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955261 on ClinicalTrials.gov