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Brief Title: Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Official Title: A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Study ID: NCT00044889
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. This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Los Angeles, California, United States
, Washington, District of Columbia, United States
, Jacksonville, Florida, United States
, Chicago, Illinois, United States
, St. Louis, Missouri, United States
, Omaha, Nebraska, United States
, Buffalo, New York, United States
, Durham, North Carolina, United States
, Memphis, Tennessee, United States
, Houston, Texas, United States
, Norfolk, Virginia, United States
, Seattle, Washington, United States
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR