Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"
1.1 Primary Objective:
1. To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta)
using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to
250 mcg. When that dose is reached, if possible, the dose of Neulasta will be
increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose
with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to
nadir or zenith blood counts.
1.2 Secondary Objective:
2. To generate preliminary pilot data as to the effectiveness of the regimen in inducing
very early remissions as measured by the CT-PET scan technique.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
up to 3 years
Fernando Cabanillas, MD
United States: Food and Drug Administration