Clinical Trial

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

Recruiting Phase 1/2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-08-06; most recent amendment 2026-04-02.
Status change: Not Yet Recruiting → Recruiting 2023-06-01
Trial Details
NCT Number NCT04049539
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, Persistent Disease, Refractory Acute Myeloid Leukemia
Enrollment 28 participants
Start Date 2021-01-29
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08