Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS

Adult patients who are at least 18 years old with histologically confirmed disease as follows:

• Standard or poor cytogenetic risk acute myelogenous leukemia (AML) according to the Southwestern Oncology Group (SWOG) criteria in first relapse or primary refractory status
• Untreated high-risk myelodysplastic syndrome (MDS) defined as >10% blasts
• Chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing imatinib therapy.
• Selected elderly patients with untreated AML who are at high risk of anthracycline toxicity.

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
• Laboratory values obtained less than or equal to 7 days prior to receiving study treatment:
• Total bilirubin < 2.0 mg/dL unless elevated due to hemolysis
• Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 5 × upper limit of normal (ULN)
• Serum creatinine < 2.0 mg/dL
• Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria

• Patients with FAB M3 unless relapsed after treatment with ATRA and arsenic trioxide.
• Patients eligible to receive curative allogeneic transplant as determined by performance status, organ function, availability of a matched donor, etc.
• Current concomitant chemotherapy, radiation therapy, or immunotherapy.
• Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
• Active heart disease including myocardial infarction within the preceding 3 months.
• History of severe coronary artery disease, arrhythmias other than atrial flutter or fibrillation requiring medication, or uncontrolled congestive heart failure
• Dyspnea at rest or with minimal exertion.
• Patients with an active, uncontrolled systemic infection considered to be opportunistic, life-threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).
• Pregnant or lactating patients.
• Prior enrollment in this trial.
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.