RecruitingInterventionalPhase 3Last updated May 19, 2026

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Overview

ClinicalTrials.gov ID: NCT05183035
Lead Sponsor: PedAL BCU, LLCOTHER
Brief 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.
Study Type

Status

Overall Status: Recruiting
Start Date: Oct 1, 2022Actual
Primary Completion Date: Feb 2027Estimated
Completion Date: Apr 2031Estimated

Study Record Dates

First Submitted: Dec 21, 2021
First Submitted that Met QC Criteria: Dec 21, 2021
First Posted: Jan 10, 2022Actual
Last Update Submitted that Met QC Criteria: May 18, 2026
Last Update Posted: May 19, 2026Actual
Last Verified: May 2026

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