A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

Inclusion Criteria:

* Have a diagnosis of ALL and confirmed by pathologic assessment.
* Be ≤ 21 years old at time of initial diagnosis.
* Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
* Must not be eligible for therapy of higher curative potential.
* Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥ 30.
* Provide a signed, written informed consent from parent or guardian or young adult patients.
* Be able to comply with study procedures and follow-up examinations.
* Have adequate cardiac function without treatment.
* Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.

Exclusion Criteria:

* Received previous treatment with clofarabine.
* Patients with isolated extramedullary disease.
* Have received prior BMT or PBSCT within the last 6 months.
* Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.
* Have an active, uncontrolled systemic infection.
* Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
* Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
* Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
* Have any other severe concurrent disease.
* Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
* Have CNS disease.