A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
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.
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
CLO212
NCT00042341
May 2002
January 2006
Name | Location |
---|---|
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
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 |