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