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

Part of paid clinical trials in Sacramento, California.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT04049539
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposome-encapsulated Daunorubicin-Cytarabine — DRUG
    Given IV

Study Details

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.

Key Dates

First listed
Aug 8, 2019
Start date
Jan 29, 2021
Status verified
Sep 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (liposome-encapsulated daunorubicin-cytarabine)
    Within 14-33 days after the start of previous cycle of chemotherapy, patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 60 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Gregory K. Behbehani, MD, PhD
[email protected]
Ana Swatzell
[email protected]
614-685-9573
Gregory K. Behbehani, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UC Davis Comprehensive Cancer Center· Sacramento, CAOhio State University Comprehensive Cancer Center· Columbus, OH

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