NCT04049539

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate the safety and estimate the efficacy of liposome-encapsulated daunorubicin-cytarabine (Vyxeos) in acute myeloid leukemia (AML) patients who have failed to achieve a hypocellular marrow after an initial course of 7+3. SECONDARY AND/OR EXPLORATORY OBJECTIVES: I. Determination of rate of morphologic leukemia-free state (MLFS). II. Determination of progression-free survival (PFS), and overall survival (OS) at 2 years. III. Mass cytometric measurement relative clearance of quiescent leukemia stem/repopulating cells (LSCs) and blasts as compared to the same patient's preceding cycle of 7+3 and to a separate control population receiving re-induction with traditional 7+3. IIIa. Measurement of blast cell cycle fraction before and after Vyxeos treatment. IIIb. Relative clearance immunophenotypically abnormal blast and stem cells after Vyxeos. IIIc. Comparison of efficacy of blast cell and LSC elimination in patients receiving Vyxeos re-induction compared to similar blast cells and LSCs in patients receiving standard 7+3 or 5+2 re-induction. OUTLINE: Within 14-33 days after the start of previous cycle of chemotherapy, patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up weekly for 60 days, then at least monthly for 2 years.

Conditions

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

Interventions

Type	Name	Description
DRUG	Liposome-encapsulated Daunorubicin-Cytarabine	Given IV

Timeline

• Start date: 2021-01-29
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-08-08
• Last updated: 2026-04-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study