Clinical trial NCT00273884 (phase 2, status: completed)
Conditions: acute myeloid leukemia
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: amonafide l-malate, cytarabine
SMILES: CN(C)CCN1C(=O)C2=CC=CC3=CC(N)=CC(C1=O)=C23, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of AML (≥20% blasts of myeloid lineage in bone marrow), with FAB
             classification other than M3, secondary to either:

               1. Known and documented exposure to prior leukemogenic chemotherapy or radiotherapy,
                  OR

               2. Diagnosis of MDS for ≥3 months prior to study entry (prior BM slides documenting
                  MDS must be available for central pathology review).

          -  Age 18 years or older.

          -  ECOG performance status ≤2.

          -  No prior induction chemotherapy for AML; at least 4 weeks since completion of prior
             chemotherapy for MDS. (Subjects with rapidly rising blast count may be enrolled within
             4 weeks of prior cytotoxic chemotherapy).

          -  Fertile and sexually active men and women must use effective contraception throughout
             study. Women of childbearing potential must have a negative pregnancy test.

          -  LVEF ≥50% by MUGA or ECHO.

          -  Adequate renal function: serum creatinine ≤1.5 x ULN.

          -  Adequate hepatic function: total serum bilirubin ≤1.5 x ULN as well as serum AST and
             ALT ≤1.5 x ULN.

          -  Subject must be able to participate fully in all aspects of the trial.

          -  Subject must give voluntary, written consent and HIPAA authorization (US only).

        Exclusion Criteria:

          -  Histologic diagnosis of FAB M3 AML (acute promyelocytic leukemia).

          -  Clinically active CNS leukemia.

          -  Known to be HIV positive.

          -  Prior induction chemotherapy for AML.

          -  Known active hepatitis B or C or other active liver disease.

          -  Any major surgery or radiation therapy within 4 weeks prior to study entry.

          -  Prior cytotoxic chemotherapy within 4 weeks prior to study entry.(Subjects with
             rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic
             chemotherapy).

          -  Persistent chronic non-hematologic toxicity from prior chemotherapy (other than
             alopecia) that is > than grade 1.

          -  Serious concomitant illness (e.g., active pulmonary infection, unstable angina or
             myocardial infarction within 3 months of study entry, congestive heart failure ≥AHA
             class 2, stroke within 3 months prior to study entry, uncontrolled hypertension,
             uncontrolled diabetes, actively bleeding gastric ulcer, etc.).

          -  Women who are pregnant or lactating.

          -  History of clinically significant allergic reactions attributed to compounds similar
             to amonafide or cytarabine.

          -  Prior enrollment on this trial.

          -  Any other known condition (familial, sociological, or geographic) or behavior
             (including substance abuse, psychological or psychiatric illness), which in the
             investigator's opinion would make the subject a poor candidate for this trial.