RecruitingPhase IIEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Rozpoznanie ostrej białaczki szpikowej potwierdzające kryteria WHO
  • •Wiek powyżej 28 dni i poniżej 22 lat
  • •Bez poprzedniej chemioterapii (z pewnymi wyjątkami)
  • •U dziewczynek w wieku prokreacyjnym: ujemny test ciążowy
  • •Dziewczęta i chłopcy w wieku rozrodczym: zgoda na antykoncepcję przez leczenie i 6 miesięcy po
  • •Pisemna zgoda pacjenta i rodziców lub opiekunów prawnych
  • •Prawidłowe wyniki badań wątroby

✗ Disqualifies

  • •Białaczka wywołana wcześniejszym leczeniem lub zespoły genetyczne związane z brakiem szpiku
  • •Zakaźnie lub poważne inne choroby zagrażające bezpieczeństwu
  • •Poprzednia ekspozycja na antracykliny
  • •Stosowanie silnych leków wpływających na metabolizm venetoclaxu

Simplified criteria — AI translation

Trial details

Minimum age
29 Days
Maximum age
21 Years
Last updated (source)
September 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (10)

Valley Children's Hospital

Madera, United States

Children's Hospital of Orange County

Orange, United States

Rady Children's Hospital-San Diego

San Diego, United States

Children's National Medical Center

Washington D.C., United States

Ann & Robert H. Lurie Children's Hospital

Chicago, United States

Dana-Farber Cancer Institute

Boston, United States

Novant Health Presbyterian Medical Center

Charlotte, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, United States

St. Jude Children's Research Hospital

Memphis, United States

Cook Children's Medical Center

Fort Worth, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/18/2026.

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