OncoMatch/Clinical Trials/NCT04049539
Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction
Is NCT04049539 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Liposome-encapsulated Daunorubicin-Cytarabine for blasts more than 5 percent of bone marrow nucleated cells.
Treatment: Liposome-encapsulated Daunorubicin-Cytarabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: RUNX1T1 t(8;21)
core binding factor AML (defined as presence of t(8;21), inv(16), or other cytogenetically equivalent abnormalities)
Excluded: CBFB inv(16)
core binding factor AML (defined as presence of t(8;21), inv(16), or other cytogenetically equivalent abnormalities)
Excluded: TP53 inactivating mutation
inactivating mutations of TP53 or evidence of an absence of p53 protein activity as indicated by a monosomal karyotype
Excluded: TP53 absence of p53 protein activity
evidence of an absence of p53 protein activity as indicated by a monosomal karyotype
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: cytarabine and anthracycline-based induction chemotherapy (cytarabine, daunorubicin, idarubicin) — induction for AML
Patients must have received standard induction chemotherapy (cytarabine 100-200mg/m2 by continuous infusion on days 1-7 and either daunorubicin 45-90mg/m2 or idarubicin 10-12mg/m2 daily for 3 days during days 1-7) within the 14-33 days prior to starting trial treatment and have documented persistent disease (13-29 days from the start of 7+3 treatment).
Cannot have received: anthracycline (daunorubicin)
Exception: lifetime daunorubicin dose of more than 462 mg/m^2 (including recent course of 7+3) or equivalent total doses of other anthracycline medications
Total lifetime daunorubicin dose of more than 462 mg/m^2 (including recent course of 7+3) or equivalent total doses of other anthracycline medications.
Lab requirements
Kidney function
Calculated creatinine clearance > 40 mL/min OR serum creatinine < 1.5 x ULN
Liver function
AST < 5 x ULN; ALT < 5 x ULN; total bilirubin < 1.5 x ULN (except for patients with known Gilbert’s syndrome)
Cardiac function
Normal left ventricular ejection fraction (>= 50% by echocardiography or MUGA) and lifetime daunorubicin dose of less than 462mg/m^2 (including recent course of 7+3), or equivalent doses of another anthracycline medications
Normal left ventricular ejection fraction (>= 50% by echocardiography or MUGA) and lifetime daunorubicin dose of less than 462mg/m^2 (including recent course of 7+3), or equivalent doses of another anthracycline medications. AST < 5 x ULN; ALT < 5 x ULN; total bilirubin < 1.5 x ULN (except for patients with known Gilbert’s syndrome); Calculated creatinine clearance > 40 mL/min OR serum creatinine < 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Davis Comprehensive Cancer Center · Sacramento, California
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04049539 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anthracycline disqualifies patients from enrollment.
Are patients with RUNX1T1 alterations eligible?
No. RUNX1T1 t(8;21) is an exclusion criterion.
Are patients with CBFB alterations eligible?
No. CBFB inv(16) is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages