Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF as Support for Dose Dense CHOP-R Front Line Therapy for Aggressive Non-Hodgkin's Lymphoma
- To identify the ideal dose of the combination of dose-dense cyclophosphamide,
doxorubicin hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP)
front-line therapy with first a fixed-dose of pegfilgrastim and an escalating-dose of
sargramostim in patients with aggressive stage I-IV non-Hodgkin lymphoma.
- To generate preliminary pilot data as to the effectiveness of this regimen in inducing
very early remissions as measured by the CT-PET scan.
OUTLINE: This is a dose-escalation study of sargramostim.
Patients receive rituximab IV on day 1 and CHOP chemotherapy comprising cyclophosphamide IV
over 15 minutes, doxorubicin Hydrochloride IV over 15 minutes, and vincristine sulfate IV
over 15 minutes on day 2 and oral prednisone once daily on days 1-5. Patients also receive
pegfilgrastim subcutaneously (SC) on day 3 and sargramostim SC 3 days a week. Treatment
repeats every 14 days for up to 6* courses in the absence of unacceptable toxicity.
NOTE: *Patients with stage IA presentation with low beta 2-microglobulin and low LDH are
treated with 3 courses of CHOP-R followed by involved-field radiation.
Blood samples are collected periodically for laboratory studies.
After completion of study therapy, patients are followed up for at least 1 month.
Masking: Open Label, Primary Purpose: Treatment
Ideal dose of sargramostim administered with dose-dense cyclophosphamide, doxorubicin Hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP), plus fixed-dose of pegfilgrastim
Fernando Cabanillas, MD
Auxilio Mutuo Cancer Center