Spots Global Cancer Trial Database for Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
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Trial Identification
Brief Title: Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
Official Title: A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Study ID: NCT00042354
Conditions
Interventions
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 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Children's Hospital, Los Angeles, California, United States
Children's Hospital, Orange County, California, United States
Children's Hospital, San Diego, California, United States
Children's Hospital, Denver, Colorado, United States
University of Connecticut Health Center, Hartford, Connecticut, United States
Children's Memorial Hospital, Chicago, Illinois, United States
Johns Hopkins Children's Center, Baltimore, Maryland, United States
Children's Hospital, St. Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Memorial Sloan-Kettering, New York, New York, United States
Children's Hospital, Philadelphia, Pennsylvania, United States
Children's Hospital, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Children's Medical Center, Dallas, Texas, United States
Cook's Children's Medical Center, Fort Worth, Texas, United States
Texas Children's Cancer Center, Houston, Texas, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR
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