A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is primarily to assess the safety, tolerability and
pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with
relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with
greater potential clinical benefit exists. The dosing regimen for the intravenous (IV)
clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to
document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK)
promoter polymorphism on PK and treatment outcome.