NCT00042354

Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients

A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Myelogenous Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 Myelogenous Leukemia (AML.)

Detailed description

This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute myelogenous leukemia (AML). Eligible patients must be in first 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.

Conditions

• Leukemia, Myelocytic, Acute, Pediatric

Interventions

Type	Name	Description
DRUG	clofarabine (IV formulation)

Timeline

• Start date: 2002-05-01
• Completion: 2004-08-01
• First posted: 2002-08-01
• Last updated: 2015-03-05

Locations

18 sites across 1 country: United States