Clinical trial NCT01035502 (phase 2, status: completed)
Conditions: acute myeloid leukemia
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: elacytarabine plus idarubicin
SMILES: [H]\C(CCCCCCCC)=C(\[H])CCCCCCCC(=O)OC[C@@]1([H])O[C@@]([H])(N2C=CC(=N)N=C2O)[C@@]([H])(O)[C@]1([H])O
Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a confirmed diagnosis of AML according to WHO classification (excluding
             acute promyelocytic leukaemia)

          2. Patients who have received one previous standard dose ara-C-containing regimen aiming
             at induction of complete remission (CR) and who have more than 5 % remaining blast
             cells in bone marrow following the first course of remission-induction or by other
             means documented residual disease (i.e. circulating blasts, persistent chloromas,
             other evident disease from day 12 on).

          3. Patients from whom samples for determination of hENT1 status on leukemic blast cells
             can be taken and prepared at diagnosis and/or at baseline

          4. Patients must be 18 years of age or older

          5. Patients must have ECOG performance status (PS) of 0 - 2

          6. Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or
             2D ECHO within 14 days prior to start of therapy.

          7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
             sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to
             beginning treatment on this study

          8. Male and female patients must use acceptable contraceptive methods for the duration of
             time on study, and males also for 3 months after the last elacytarabine dose

          9. Patients must be capable of understanding and complying with parameters as outlined in
             the protocol, and able and willing to sign a written informed consent form

         10. Patients must have the following clinical laboratory values:

               -  Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)

               -  Total bilirubin <= 1.5 x the ULN according to national prescribing information
                  unless considered due to Gilbert's syndrome

               -  Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT)
                  <= 2.5 x the ULN unless considered due to organ leukemic involvement

         11. Patients must be eligible for administration of idarubicin according to current
             national prescribing information for idarubicin

        Exclusion Criteria:

          1. A history of allergic reactions to egg, idarubicin and/or other anthracyclines or
             other components of the products. A history of allergic reactions to ara-C of CTCAE
             grade 3 or 4

          2. Persistent clinically significant and relevant toxicities from the previous course of
             chemotherapy

          3. A cancer history, that according to the investigator might confound the assessment of
             the study endpoints

          4. Patients with prior treatment with a cumulative dose of doxorubicin or equivalent
             exceeding 300 mg/m2 according to the following calculation index: X/300 + Y/160 < 1
             where X is the doxorubicin or equivalent dose in mg/m2 and Y is the mitoxantrone dose
             in mg/m2. These calculations are to be used as guidance as there is no maximum
             cumulative dose defined in the summary of product characteristics (SPC) for
             idarubicin. The patient should tolerate minimum one course of combination therapy

          5. Active heart disease including myocardial infarction within the previous 3 months,
             symptomatic coronary disease, arrhythmias not controlled by medication, or
             uncontrolled congestive heart failure. Any NYHA grade 3 or 4

          6. Known positive status for human immunodeficiency virus (HIV)

          7. Pregnant and nursing patients are excluded because the effects of elacytarabine on a
             fetus or a nursing child are unknown

          8. Uncontrolled intercurrent illness including, but not limited to uncontrolled
             infection, or psychiatric illness/social situations that may reduce compliance with
             study requirements

          9. Patients receiving hydroxyurea within the last 12 hours prior to treatment on this
             protocol or any other investigational or standard cytotoxic treatment within the last
             14 days, except the first remission-induction course

         10. Any medical condition, which in the opinion of the investigator places the patient at
             an unacceptably high risk for toxicities