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Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

NCT05183035 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-05-19

No results posted yet for this study

Summary

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Conditions

Interventions

DRUG

Fludarabine

Intravenous (IV) infusion

DRUG

Cytarabine

Intravenous (IV) infusion

DRUG

Gemtuzumab Ozogamicin

Intravenous (IV) infusion

DRUG

Azacitidine

Intravenous (IV) infusion or subcutaneous injection

DRUG

Venetoclax

Orally via tablet or powder suspension

Sponsors & Collaborators

  • Princess Maxima Center for Pediatric Oncology (European Sponsor)

    collaborator UNKNOWN

  • AbbVie

    collaborator INDUSTRY

  • Roche-Genentech

    collaborator INDUSTRY

  • EuPAL

    collaborator UNKNOWN

  • PedAL BCU, LLC

    lead OTHER

Principal Investigators

  • Seth Karol, MD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2027-02-28
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Portugal
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

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 NCT05183035 on ClinicalTrials.gov