| Exclusion Criteria: | 1) Received previous treatment with clofarabine
2) Received intermediate- or high-dose cytarbine (IDAC or HDAC, respectively) defined as a bolus administration schedule at >/= 500 mg/m^2/dose as a component of prior induction or consolidation therapy, unless both the following criteria are met: 1) the total duration of remission following the most recent IDAC- or HDAC-containing regimen exceeds 6 months, as measured from the time of documented remission (CR or CRi) with that regimen; and 2) the remission duration following the last day of IDAC or HDAC exposure exceeds 3 months.
3) Have received an HSCT within the previous 3 months prior to study entry.
4) Have >/= grade 2 acute graft versus host disease (GvHD).
5) Have either moderate or severe chronic GvHD, whether limited or extensive chronic GvHD. Patients with mild limited or extensive chronic GvHD may be included.
6) Are receiving any other systemic antileukemic therapy (standard or investigational). Patients must not have received previous therapy for at least 2 weeks prior to the first dose of study drug and must have recovered from any prior drug-related non-hematologic toxicity to </= grade 2, with the following exceptions: (a) hydroxyurea, which must not have been received < 24 hours prior to the first dose of study drug; (b) monoclonal antibodies, which must not have been received for 6 weeks prior to the first dose of study drug.
7) Have psychiatric disorders that would interfere with consent, study participation, or follow-up.
8) Have a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibioitics or other treatment).
9) Have been diagnosed with another malignancy, unless the patient has been disease free for at least 5 years following curative intent therapy, with the following exceptions: Patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA values if hormonal therapy has been initiated or a radical prostatectomy has been performed.
10) Have clinical evidence suggestive of CNS involvement with leukemia unless a lumber puncture confirms the absence of leukemic blasts in the CSF.
11) Known HIV positivity.
12) Are pregnant or lactating.
13) Have any 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 induction therapy with either or both of these agents. |