Clinical trial NCT01066494 (phase 2, status: unknown status)
Conditions: acute myeloid leukemia
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: amonafide + cytarabine
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent

          2. In the opinion of the Investigator able to comply with the study assessments and
             follow-up

          3. New diagnosis of AML (i.e. >20 % blasts) as defined by the World Health Organization
             (WHO) classification (Vardiman 2009) or relapsed or refractory AML as defined by the
             persistence or recurrence of >5% blasts in bone marrow or peripheral blood following
             treatment.

          4. ECOG Performance status ≤ 2

          5. Age > 18 years and ≤ 70 years

          6. Adequate hepatic function as evidenced by the following laboratory tests:

               1. Total serum bilirubin ≤ 1.5 x ULN or direct (conjugated) bilirubin ≤ 1.5 ULN
                  unless attributable to suspected hepatic involvement with AML

               2. Serum AST and ALT ≤ 1.5 x ULN unless attributable to suspected hepatic
                  involvement with AML

          7. Adequate renal function as evidenced by serum creatinine ≤ 1.5 x ULN

          8. Women of childbearing potential must have a negative serum pregnancy test. A woman of
             childbearing potential is defined as one who is biologically capable of becoming
             pregnant. This includes women who are using contraceptives or whose sexual partners
             are either sterile or using contraceptives

          9. Left Ventricular Ejection Fraction (LVEF) > 50%, as determined by multiplegated
             acquisition scan (MUGA) or echocardiogram (ECHO) within 28 days prior to
             administration of 1st dose of remission induction chemotherapy

        Exclusion Criteria:

          1. Unwilling to accept the required per protocol blood and urine sample collection

          2. An initial diagnosis of acute promyelocytic leukemia as defined by French-
             American-British criteria (Bennett 1976) (otherwise known as FAB M3)

          3. Clinically active CNS leukemia

          4. History of clinically significant allergic reactions attributed to compounds of
             similar chemical or biological composition to amonafide or cytarabine

          5. Pregnant or breast feeding

          6. Known HIV positive

          7. Known active hepatitis B or C, or any other active liver disease

          8. Evidence of pulmonary infection. Patients with evidence of pulmonary infection on
             screening chest x-ray should have chest computed tomography (CT) prior to starting
             remission induction therapy to confirm absence or presence of pulmonary infection.

          9. Any major surgery or radiation therapy within 30 days prior to study entry

         10. Previously received treatment with amonafide

         11. Treatment with other investigational agents for any reason within 30 days prior to
             study entry

         12. Prior remission induction therapy for AML within 30 days of starting amonafide therapy

         13. Persistent non-hematologic toxicity (other than alopecia) greater than Grade 2 from
             prior therapy for MDS or AML

         14. Serious concomitant illnesses (for example, unstable angina or myocardial infarction
             or stroke within 3 months prior to study entry, congestive heart