# Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

> **NCT05183035** · PHASE3 · RECRUITING · sponsor: **PedAL BCU, LLC** · enrollment: 130 (estimated)

## Conditions studied

- Acute Myeloid Leukemia

## Interventions

- **DRUG:** Fludarabine
- **DRUG:** Cytarabine
- **DRUG:** Gemtuzumab Ozogamicin
- **DRUG:** Azacitidine
- **DRUG:** Venetoclax

## Key facts

- **NCT ID:** NCT05183035
- **Lead sponsor:** PedAL BCU, LLC
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-10-01
- **Primary completion:** 2027-02
- **Final completion:** 2031-04
- **Target enrollment:** 130 (ESTIMATED)
- **Last updated:** 2026-04-28

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05183035

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05183035, "Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT05183035. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
