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NCT05183035 · ClinicalTrials.gov record · last posted 2026-08-24

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Name: Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) — clinical trial record (NCT05183035)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorPedAL BCU, LLC

Started2022-10-01

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 1 change detected by DataLookout

2026-04-29

Enrollment increased: 98 → 130 participants

Trial Details

NCT Number	NCT05183035
Lead Sponsor	PedAL BCU, LLC Collaborators: Princess Maxima Center for Pediatric Oncology (European Sponsor), AbbVie, Roche-Genentech, EuPAL
Conditions	Acute Myeloid Leukemia
Enrollment	130 participants
Start Date	2022-10-01
Primary Completion	2027-02 (estimated)
Study Completion	2031-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-24