Actively Recruiting
Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-08
28
Participants Needed
2
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Diagnosis of acute myeloid leukemia
- Received standard induction chemotherapy with cytarabine and daunorubicin or idarubicin within 14-33 days before starting trial treatment
- Documented persistent disease after initial treatment, defined by bone marrow cellularity over 10-20% and blasts over 5-10% or abnormal leukemia cells
- Deemed unlikely to achieve complete response without further therapy
- Able to tolerate intensive chemotherapy
- Normal left ventricular ejection fraction (>= 50%) and lifetime daunorubicin dose under 462 mg/m2
- ECOG functional status of 0, 1, or 2
- Liver enzymes (AST and ALT) less than 5 times the upper limit of normal
- Total bilirubin less than 1.5 times the upper limit of normal (except for Gilbert's syndrome)
- Kidney function with creatinine clearance over 40 mL/min or serum creatinine less than 1.5 times upper limit
- Female patients of childbearing potential must use two forms of contraception and have a negative pregnancy test
- Male patients with female partners of childbearing potential must use contraception or abstain and avoid sperm donation during and for 6 months after treatment
You will not qualify if you...
- Acute promyelocytic leukemia (M3 AML)
- Known core binding factor AML with certain genetic abnormalities
- Inactivating TP53 mutations or absence of p53 protein activity
- Unable to tolerate intensive chemotherapy
- History of severe allergic reactions to cytarabine, daunorubicin, or formulation components
- Known Wilson's disease or symptomatic copper metabolism abnormalities
- Total lifetime daunorubicin dose over 462 mg/m2
- Pregnancy or inability to use effective contraception for 6 months after treatment
- Breastfeeding within 14 days after last Vyxeos dose
- Uncontrolled infection not yet treated
- Recent use of investigational agents without recovery from toxicity
- Psychological, social, or geographic factors preventing consent or compliance
- Other medical conditions or psychiatric illness that preclude participation
- Uncontrolled serious heart conditions or recent myocardial infarction
- Other active malignancies requiring treatment, except minor skin cancer surgery or hormonal therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here