Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

November 30, 2010

Study Completion Date

March 31, 2011

Conditions
LymphomaNon Hodgkin's Lymphoma
Interventions
DRUG

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.

Trial Locations (1)

00919

Hospital Auxilio Mutuo Cancer Center, San Juan

All Listed Sponsors
collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

Fernando Cabanillas

OTHER

NCT01527422 - Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL | Biotech Hunter | Biotech Hunter