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

NCT03826992 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-18

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • John Perentesis, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826992 on ClinicalTrials.gov