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

StatusRecruiting
PhasePhase 1/2
Started2021-01-29
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 31, 2026 → May 31, 2027
See other at-risk trials from Ohio State University Comprehensive Cancer Center

Amendment history

2026-09-04
Study Status, Contacts/Locations v5
Primary completion pushed: 2026-12-31 → 2027-05-31
Completion pushed: 2026-12-31 → 2027-05-31
Study sitesdetails revised at 1 of 2 sites
2026-04-02
Study Status, Oversight, Eligibility v4
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
Eligibility criteria+379 characters
Inclusion Criteria: Subject or their legal guardian must be able to provide written informed consent Patients m [...] acute myeloid leukemia Patients must have received standard continuousinduction infusion cytarabine and daunorubicinchemotherapy (cytarabine 100-200 mg200mg/m^2m2 by continuous infusion on days 1-7 and either daunorubicin 45-9090mg/m2 mgor idarubicin 10-12mg/m^2 onm2 daily for 3 days during days 1-37) within the 14-33 days prior to starting trial treatment an [...] atment). Patients who have received a 7+3 regimen utilizing idarubicingemtuzumab (12ozogamicin mg/m^2may onenroll. Patients days [...]
2025-02-28
Study Status, Oversight v3
Primary completion date2024-12-31→2025-12-31
Completion date2024-12-31→2025-12-31
2023-09-05
Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v2
Primary completion date2023-12-31→2024-12-31
Completion date2023-12-31→2024-12-31
Enrollment target44→28
Study description-4 characters
[...] eiving standard 7+3 or 5+2 re-induction. OUTLINE: Within 14-2633 days after the start of previous cycle of chemotherapy, pat [...] icin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 53 in the absence of disease progression or unacceptable toxic [...]
Study sitesdetails revised at 1 of 2 sites
2023-06-01
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Design, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
PhasePhase 2→Phase 1/2
Primary completion date2021-12-31→2023-12-31
Completion date2021-12-31→2023-12-31
Start dateestimated 2019-10-31→confirmed 2021-01-29
Enrollment target37→44
Study sites1→2
Eligibility criteriarevised
[...] -7 and daunorubicin 45-90 mg/m^2 on days 1-3) within the 14-2633 days prior to starting trial treatment and have documented persistent disease (13-2229 days from the start of 7+3 treatment). Patients who have re [...]
Collaborators-31 characters
National Cancer Institute (NCI)
2019-08-06
Original filing
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.
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 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-09