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Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
This study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.
Official title: A Phase I Study of Venetoclax Combined With Vyxeos (CPX-351) for Children, Adolescents and Young Adults With Relapsed or Refractory Acute Leukemia
Key Details
Gender
All
Age Range
1 Year - 39 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2018-12-27
Completion Date
2028-01
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Vyxeos
Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.
Venetoclax
Venetoclax Dose: 1. Dose Level 0 - weight based daily dosing for 21 days 2. Dose Level -1 - weight based daily dosing for 14 days 3. Dose Level -2- weight based daily dosing for 10 days 4. Dose Level -3- weight based daily dosing for 7 days
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States