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RECRUITING
NCT03826992
PHASE1

Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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