Neoplasms

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Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

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All Drugs and Chemicals

Amino Acids

Cytarabine

Venetoclax

Daunorubicin

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Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Lysine

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.

Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.

Vyxeos

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

Site Pulblic Contact

Site Public Contact

John Perentesis, MD

Laura Agresta, MD

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.

This is a single-institution Phase I pilot study designed to test the safety and tolerability of combining venetoclax with Vyxeos (CPX-351, cytarabine and daunorubicin liposome) for the treatment of relapsed/refractory acute leukemia in young patients. Subjects will receive a single course of study therapy consisting of daily, oral venetoclax at an assigned dose level with a 3-day ramp-up to target dose and Vyxeos administered intravenously at the established dose on Days 1, 3, and 5. In addition to safety and tolerability, the overall response rate to these therapies will be estimated. Pharmacokinetic (PK) analysis will also be conducted to define the drug clearance of venetoclax in this combination.

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

A Phase I Study of Venetoclax Combined With Vyxeos (CPX-351) for Children, Adolescents and Young Adults With Relapsed or Refractory Acute Leukemia

If 2 or more participants have dose limiting toxicities at a given dose level, the maximum tolerated dose will have been exceeded.

Estimate of overall response rate (ORR) defined as (CR/CRi/CRp).

Children's Hospital Medical Center, Cincinnati

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia	NCT03826992	Leukemia	Vyxeos Venetoclax	1 Year - 39 Years	Children's Hospital Medical Center, Cincinnati
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia	NCT03826992	Leukemia	Vyxeos Venetoclax	1 Year - 39 Years	Children's Hospital Medical Center, Cincinnati

Spots Global Cancer Trial Database for acute myeloid leukemia, childhood