VyClo ITCC-092

Lab values

• evidence of a currently uncontrolled bacterial, viral or parasitic infection • evidence of a fungal infection, defined as either: - Pulmonary infiltrates suggestive of a fungal infection at HR-CT (within 3 weeks prior to enrollment) - Positive Aspergillus serum test (galactomannan), according to local laboratory practice (within 3 weeks prior to enrollment) • evidence of isolated extramedullary relapse, including isolated CNS-relapse • evidence of CNS3 or symptomatic CNS leukemia • Down Syndrome • evidence of relapsed/refractory acute promyelocytic leukemia (APL) • use of any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy (note: hematological toxicities do not need to be considered since the patient has overt leukemia) • history of prior veno-occlusive disease (VOD) • known hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin • known copper metabolism deficiency, such as Wilson's disease.

• Any ≥ 2nd relapse of AML • Refractory AML (defined as ≥ 20% blasts in the bone marrow after standard (re-) induction therapy) • Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML • Any relapse of AML after prior allogenic HSCT • Any relapse of AML with high risk cytogenetic characteristics • Complete initial work-up within 7 days prior to study entry, including bone-marrow aspiration, lumbar puncture (without intrathecal therapy) • Lansky play score ≥ 60 for patients <16 years of age; or Karnofsky performance status ≥ 60 for patients ≥ 16 years of age • Life expectancy > 6 weeks • a calculated GFR ≥ 70mL/min/1.73 m2 • Liver function: total serum bilirubin ≤ 3 mg/dl or 50 µmol/L and aspartate transaminase (AST) and alanine transaminase (ALT) ≤200 U/L • Adequate cardiac function (defined as shortening fraction ≥28% or ejection fraction ≥50%)