60
Participants
Start Date
January 31, 2006
Primary Completion Date
November 30, 2010
Study Completion Date
March 31, 2011
Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3.
Hospital Auxilio Mutuo Cancer Center, San Juan
Genzyme, a Sanofi Company
INDUSTRY
Fernando Cabanillas
OTHER