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 (May 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
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: TP53 inactivating mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy (cytarabine, daunorubicin) — induction
Patients must have received standard continuous infusion cytarabine and daunorubicin (cytarabine 100-200 mg/m^2 by continuous infusion on days 1-7 and daunorubicin 45-90 mg/m^2 on days 1-3) 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). Patients who have received a 7+3 regimen utilizing idarubicin (12 mg/m^2 on days 1-3) in place of daunorubicin may enroll.
Cannot have received: investigational agent
Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.
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); lifetime daunorubicin dose of less than 418 mg/m^2 (including recent course of 7+3)
Normal left ventricular ejection fraction (>= 50% by echocardiography or multi-gated acquisition radionuclide angiocardiography [MUGA]) and lifetime daunorubicin dose of less than 418 mg/m^2 (including recent course of 7+3); 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 (according to the Cockcroft-Gault equation) > 40 mL/min OR serum creatinine < 1.5 x the ULN for the local laboratory
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
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