RecruitingPhase 1Phase 2NCT04049539

Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction

Open-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

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

28 participants

Start Date

Jan 29, 2021

Study Type

INTERVENTIONAL

Conditions

Refractory Acute Myeloid Leukemia Blasts More Than 5 Percent of Bone Marrow Nucleated Cells Persistent Disease

Summary

This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cytarabine and daunorubicin given together in liposomes may have fewer side effects and work better than cytarabine and daunorubicin given alone in patients with acute myeloid leukemia.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a liposomal formulation of chemotherapy drugs (called Vyxeos — a combination of cytarabine and daunorubicin in a special fat-based delivery system) can successfully treat patients with acute myeloid leukemia (AML) whose cancer didn't go into remission after the standard first treatment. **You may be eligible if...** - You have been diagnosed with acute myeloid leukemia (AML) - You received standard induction chemotherapy (7+3 regimen) and your leukemia is still present (persistent disease) - Your bone marrow assessment confirms persistent AML **You may NOT be eligible if...** - Your AML went into remission after initial treatment - You have received previous re-induction chemotherapy - You have severe organ problems that prevent additional chemotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposome-encapsulated Daunorubicin-Cytarabine

Given IV

Locations(2)

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT04049539

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