A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT05955261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05955261
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Interventions
- Venetoclax Drug
- Azacitidine Drug
- Cytarabine Drug
- Gemtuzumab Ozogamicin Drug
- Daunorubicin Hydrochloride Drug
- Fludarabine Phosphate Drug
- Idarubicin Hydrochloride Drug
- Mitoxantrone Hydrochloride Drug
- Etoposide Drug
- Gilteritinib Drug
Drug
Eligibility (public fields only)
- Age range
- 29 Days to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2023
- Primary completion
- Nov 30, 2026
- Completion
- Feb 28, 2034
- Last update posted
- Jul 27, 2026
2023 – 2034
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Valley Children's Hospital | Madera | California | 93636 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Rady Children's Hospital-San Diego | San Diego | California | 92123 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20020 | — |
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05955261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05955261 live on ClinicalTrials.gov.