| Exclusion Criteria: | 1) Patients with Burkitt's leukemia (FAB L3-ALL) are excluded. Patients with acute promyelocytic leukemia (FAB M3-AML [APL]) with t(15;17)(q22;q12),(PML/RAR α), or any other variant, are excluded unless the patient has received both all-trans retinoic acid and arsenic trioxide as prior therapy.
2) Patients who received previous treatment with Clofarabine
3) Have an uncontrolled systemic fungal, bacterial, or other infection (eg requiring pressors, supplemental oxygen). In addition, patients must have a temperature < 38.5 degrees C for at least 48 hours prior to study enrollment including negative blood cultures at 48 hours in patients with a history of fever within the preceding 3 days.
4) Patients who are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control (ie, latex condom, diaphragm, cervical cap, etc) while on study therapy, and for a minimum of 1 month following final study visit.
5) Patients who have psychiatric disorders that would interfere with consent, study participation, or follow-up.
6) Patients who in the opinion of the investigator might not be able to comply with the safety monitoring requirements of the study.
7) Adequate time has not elapsed since pt's last tx. Pts who relapse while receiving standard ALL maintenance chemo do not need a washout period before study entry.
8) Adequate time has not elapsed since pt's last tx. Pts who relapse when they are not receiving standard ALL maintenance tx must have fully recovered from the acute toxic effects of all prior chemo (excluding hematologic toxicity), immunotherapy, or XRT prior to 1st dose of study drug. Also for these pts at least 14 days must have elapsed since the completion of cytotoxic tx. Hydroxyurea may be given to achieve a WBC <50,000/µL prior to starting protocol tx. In these cases there must be at least 48 hrs from the last dose of hydroxyurea and the 1st dose of the study drug
9) Note: patients may receive intrathecal ara-C or methotrexate immediately up to administration of study drug. Biologic (anti-neoplastic agent): Patients must have completed therapy with a biologic agent at least 7 days prior to administration of study drug(s). For patients receiving monoclonal antibody therapy, at least 14 days must have elapsed after completion of therapy.
10) Patients who have any other severe concurrent diseas, or have a history of serious organ dysfunction or diesase involving the heart, kidney, liver or pancreas.
11) Have received a HSCT
12) Have known hepatitis B or C infection or history of cirrhosis. |