Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Inclusion Criteria:

- Adequate renal and hepatic function.

- 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.

- LVEF must be ≥ 50% within 2 weeks.

Exclusion Criteria:

- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
specified in the protocol.

- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
before study entry with the exception of hydroxyurea. The patient must have
recovered from all acute toxicities from any previous therapy.

- Have any other severe concurrent disease, or have a history of serious organ
dysfunction or disease involving the heart, kidney, liver or other organ system that
may place the patient at undue risk to undergo treatment.

- Patients with a systemic fungal, bacterial, viral, or other infection not controlled.

- 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.

- Have had a diagnosis of another malignancy, unless the patient has been disease free
for at least 3 years following the completion of curative intent therapy with the
following exceptions: patients with treated non-melanoma skin cancer, in situ
carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free
duration, are eligible for the study if definitive treatment for the condition has
been completed. Patients with organ-confined prostate cancer with no evidence of
recurrent or progressive disease based on prostate-specific antigen values are also
eligible for this study if hormonal therapy has been initiated or a radical
prostatectomy has been performed. Additionally, patients with prostate cancer
treated with radiation therapy are also eligible for the study.