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Vyxeos Treatment for Failed Initial Cycle of Standard Chemotherapy in Intermediate and High-Risk Acute Myeloid Leukemia Patients

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Study Aim

This study aims to evaluate the effectiveness and safety of Vyxeos treatment in intermediate and high-risk Acute Myeloid Leukemia patients who have not responded to the initial cycle of standard chemotherapy, by measuring the rate of complete response and incidence of adverse events.

What is being tested

Liposome-encapsulated Daunorubicin-Cytarabine

Drug
Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 18 to 75 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2021
See protocol details

Summary

Principal SponsorOhio State University Comprehensive Cancer Center
Study ContactThe Ohio State University Comprehensive Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 29, 2021

Actual date on which the first participant was enrolled.

This study is an open-label, phase 2 trial for patients with intermediate and high-risk Acute Myeloid Leukemia (AML) who have not responded well to an initial cycle of standard chemotherapy using Cytarabine and Daunorubicin. The main goal is to evaluate the safety and effectiveness of a drug called Vyxeos, which is a liposome-encapsulated form of Daunorubicin and Cytarabine. The study aims to help patients who have failed to achieve a hypocellular marrow, a condition where the bone marrow has a lower than normal number of cells, after their first round of chemotherapy. The potential outcomes of this study could lead to improved treatment options for AML patients who have not responded to standard therapies. During the study, participants will receive Vyxeos through an intravenous (IV) infusion over 90 minutes on days 1 and 3. This treatment cycle will be repeated every 14-33 days in the absence of disease progression or unacceptable toxicity. The study will measure the complete response rate and the rate of complete response with incomplete hematologic recovery. It will also monitor the incidence of adverse events such as symptomatic cardiac dysfunction, hepatic or renal toxicity, severe hemorrhage, and severe infection. After the completion of the study treatment, patients will be followed up weekly for 60 days, and then at least monthly for 2 years.

Official TitleOpen-Label Phase 2 Trial of Vyxeos in Patients With Intermediate and High-Risk Acute Myeloid Leukemia Who Have Failed an Initial Cycle of Standard Cytarabine and Daunorubicin Chemotherapy
NCT04049539
Principal SponsorOhio State University Comprehensive Cancer Center
Study ContactThe Ohio State University Comprehensive Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

13 inclusion criteria required to participate
Subject or their legal guardian must be able to provide written informed consent
Patients must have a diagnosis of acute myeloid leukemia
Normal left ventricular ejection fraction ( >= 50% by echocardiography or multi-gated acquisition radionuclide angiocardiography [MUGA]) and lifetime daunorubicin dose of less than 418 mg/m^2 (including recent course of 7+3)
Patients must have received standard continuous infusion cytarabine and daunorubicin (cytarabine 100-200 mg/m^2 by continuous infusion on days 1-7 and daunorubicin 45-90 mg/m^2 on days 1-3) within the 14-33 days prior to starting trial treatment and have documented persistent disease (13-29 days from the start of 7+3 treatment). Patients who have received a 7+3 regimen utilizing idarubicin (12 mg/m^2 on days 1-3) in place of daunorubicin may enroll. Persistent disease will be defined as bone marrow cellularity of > 10-20% and bone marrow blast percentage of > 5-10% or clear evidence of immunophenotypically aberrant leukemia cells in the bone marrow. The final determination of persistent AML will be made by the treating physician, but must meet National Comprehensive Cancer Network (NCCN) criteria for persistent disease. Enrollment of patients with less than 20% cellularity or less than 10% blasts will require approval of the principal investigator. Patients who received concomitant treatment with another targeted therapy for AML (e.g. midostaurin) during initial induction may enroll, but will not continue to receive this treatment during Vyxeos treatment
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14 exclusion criteria prevent from participating
Total lifetime daunorubicin dose of more than 418 mg/m^2 (including recent course of 7+3) or equivalent total doses of other anthracycline medications
Pregnancy or inability to use highly effective method of contraception for 6 months following last dose of Vyxeos. Potentially fertile patients must have documented negative serum pregnancy test. Breastfeeding should be avoided for at least 14 days after the last dose Vyxeos
Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control. As infection is a common feature of AML, patients with active infections are permitted to enroll provided that the infection is under control
Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the United States (US) Food and Drug Administration (FDA)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive Liposome-encapsulated Daunorubicin-Cytarabine through an IV drip on days 1 and 3, within 14-33 days after the start of previous chemotherapy cycle. This continues unless there is disease progression or unacceptable side effects.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

UC Davis Comprehensive Cancer Center

Sacramento, United StatesOpen UC Davis Comprehensive Cancer Center in Google Maps
Recruiting

Ohio State University Comprehensive Cancer Center

Columbus, United States
Recruiting
2 Study Centers