Spots Global Cancer Trial Database for Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)

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Trial Identification

Brief Title: Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)

Official Title: A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

Study ID: NCT00042341

Conditions

Leukemia, Lymphoblastic, Acute, Pediatric

Interventions

clofarabine (IV formulation)

Study Description

Brief Summary: Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Lymphoblastic Leukemia (ALL.)

Detailed Description: This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia (ALL). Eligible patients must be in second or subsequent relapse or be refractory. Forty eligible patients will be enrolled in a Fleming 2-stage sequential study design in order to better assess the efficacy and safety of clofarabine in this patient population.