23
Participants
Start Date
January 31, 2004
Primary Completion Date
April 30, 2009
Study Completion Date
August 31, 2011
clofarabine
Clofarabine should be administered by daily intravenous infusion over 2 hours.Following demonstration of DLT at Dose Level -I (22.5 mg/m2/day days 2-6) and demonstration that Dose Level -II (15mg/m2day days 2-6) is the 'optimal phase II dose', an additional Dose Level -1½ (20mg/m2/day, days 2-6) will be added to explore an increased dose of clofarabine intermediate between Dose Levels -I and -II.
Ara-C
Ara-C: Administer Ara-C by continuous infusion of 100mg/m2/day on days 1 to 7 for cycle 1, and on days 1 to 5 for cycles 2 \& 3.
University of Alabama at Birmingham, Birmingham
The Cleveland Clinic Foundation, Cleveland
The University of Nebraska, Omaha
Genzyme, a Sanofi Company
INDUSTRY
University of Alabama at Birmingham
OTHER