A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Inclusion Criteria:

- note: For inclusion and exclusion criteria, a regimen is defined as including
Induction, Consolidation, and Maintenance therapies.

- Diagnosis of AML according to FAB classification

- Must not be eligible for therapy of higher curative potential, and must be in first
or subsequent relapse and/or refractory

- A Karnofsky Performance Status (KPS) of greater than or equal to 60.

- If female of childbearing potential, patients must have a negative serum or urine
pregnancy test within 7 days of study enrollment. Men and women with reproductive
potential must use as an effective contraceptive method while enrolled in the study.
Patients must have contraceptive and/or fertility counseling prior to entering the
study, i.e., information on sperm banking, etc.

- Signed, written informed consent.

- Ability to comply with study procedures and follow-up examinations.

- Adequate organ function as indicated by specific laboratory values (defined in the
protocol), obtained within two weeks prior to registration.

- Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at
least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide
containing regimen) before being considered for this study.

Exclusion Criteria:

- note: For inclusion and exclusion criteria, a regimen is defined as including
Induction, Consolidation, and Maintenance therapies.

- Received previous treatment with CLOFARABINE.

- Received more than two previous induction regimens or cycles for the treatment of
AML.

- Relapsed > 1 year.

- Have an active, uncontrolled systemic infection considered opportunistic, life
threatening, or clinically significant at the time of treatment.

- Are pregnant or lactating.

- Have psychiatric disorders that would interfere with consent, study participation or
follow-up.

- Are receiving any other chemotherapy or corticosteroids. Patients must be off
previous therapy for at least two weeks and must have recovered from acute toxicity
of all previous therapy prior to enrollment.

- Have any other severe concurrent disease.

- Have symptomatic CNS involvement.

- Have chronic myelogenous leukemia (CML) in lymphoid blast crisis).