A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Myelogenous Leukemia
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
CLO222
NCT00042354
May 2002
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
Arkansas Children's Hospital | Little Rock, Arkansas 72202-3591 |
Children's Hospital | Los Angeles, California 90027 |
Children's Hospital | Denver, Colorado 80218 |
Children's Memorial Hospital | Chicago, Illinois 60614 |
Johns Hopkins Children's Center | Baltimore, Maryland |
Children's Hospital | St. Louis, Missouri |
Memorial Sloan-Kettering | New York, New York |
Children's Hospital | Philadelphia, Pennsylvania |
Cook's Children's Medical Center | Fort Worth, Texas 76104 |
The University of Texas M.D. Anderson Cancer Center | Houston, Texas |
Children's Medical Center | Dallas, Texas |