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

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

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.