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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT03826992
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Vyxeos — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

Start date
Dec 27, 2018
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax and Vyxeos combination
    Venetoclax will be given orally on Days per the assigned dose level. A single course consisting of 3 doses of Vyxeos and 7-21 doses of venetoclax depending on the assigned dose level will be administered to participants in this study. Vyxeos will be administered by central venous catheter over 90 minutes on Day 1, 3, and 5. Venetoclax is given daily by mouth per assigned dose level.

Primary Outcome Measure

Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities) [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Site Public Contact
[email protected]
513-636-2799
John Perentesis, MD (PRINCIPAL_INVESTIGATOR)
Laura Agresta, MD (SUB_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

Related Studies