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NCT04049539 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, sponsored by Ohio State University Comprehensive Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
28
Enrollment target
2
Study locations

NCT04049539: Recruiting Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, sponsored by Ohio State University Comprehensive Cancer Center.

NCT04049539 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 28 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04049539, a Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
28 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

Will be measured by the time to count recovery, incidence of symptomatic cardiac dysfunction, incidence of hepatic or renal toxicity, incidence of severe hemorrhage, and incidence of severe infection. Will be summarized by National Cancer Institute Common Terminology Criteria for Adverse Events version 4, and frequency counts will be tabulated with a focus on severe (grade 3+) adverse events and toxicities that are deemed at least possibly related to study treatment. The incidence of specific to

Conditions Studied

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

Interventions

  • DRUG Liposome-encapsulated Daunorubicin-Cytarabine

Study Locations (2)

California

  • UC Davis Comprehensive Cancer Center - Sacramento

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2021-01-29
Est. Completion 2025-12-31
Phase Phase 1
Ohio State University Comprehensive Cancer Center

341 total trials

What NCT04049539 shows while recruiting

NCT04049539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower).

The record links to 3 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Liposome-encapsulated Daunorubicin-Cytarabine is the first listed.

NCT04049539 reports a single indexed study location in California, Ohio.

Frequently Asked Questions

What is clinical trial NCT04049539 about?

NCT04049539 is a clinical study titled "Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction". 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 ...

What is the current status of trial NCT04049539?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-01-29. Estimated completion is 2025-12-31.

What conditions does trial NCT04049539 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, Persistent Disease.

What interventions are being tested in trial NCT04049539?

The interventions under investigation include: Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).

Who is sponsoring clinical trial NCT04049539?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04049539 being conducted?

This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04049539's enrollment target sits among peer trials

28 39th of 63 higher than 24 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04049539

Source: ClinicalTrials.gov NCT04049539, the US trial registry maintained by the National Library of Medicine. NCT04049539 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.