A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
St. Jude Children's Research Hospital
70 participants
Jul 25, 2023
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Venetoclax will be given with each course of therapy. Patients with low-risk AML will receive four courses of therapy, intermediate-risk patients will receive five courses of therapy, and high-risk patients will receive two or three courses of therapy followed by hematopoietic stem cell transplantation.
Given IV over 30 minutes on days 1-5
Given IV over 30 minutes q12 hours on days 1-8 (16 doses)
Given IV
IV over 1 hour on days 1, 3, and 5
Given IV over 30 minutes on days 1-5
Given IV over 15 minutes on days 3-5
IV over 1 hour on days 2-4
Given IV over 1 hour on days 1-5
PO on days 8-28 (21 doses)
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05955261