Randomized, Double-Blind Study Of Peripheral Blood Progenitor Cell (PBPC) Mobilization By Pegfilgrastim Or Filgrastim For Autologous Transplantation In Subjects With Hodgkin's Or Non-Hodgkin's Lymphoma
- Compare the CD34+ cells/kg yield from patients receiving single-dose pegfilgrastim (2
different doses) or daily filgrastim (G-CSF) for peripheral blood progenitor cell
(PBPC) mobilization and collection for autologous transplantation in patients with
Hodgkin's or non-Hodgkin's lymphoma.
- Compare the safety of these regimens in these patients.
- Determine the CD34+ cell dynamics and pharmacokinetics of pegfilgrastim in peripheral
blood during the collection phase in these patients.
- Evaluate engraftment of PBPC mobilized by pegfilgrastim in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to amount of prior chemotherapy or radiotherapy (heavily pretreated vs non-heavily
pretreated). Patients are randomized to 1 of 3 treatment arms.
- Peripheral blood progenitor cell (PBPC) mobilization:
- Arm I: Patients receive lower dose pegfilgrastim subcutaneously (SC) on day 1 and
placebo SC on days 1-9.
- Arm II: Patients receive higher dose pegfilgrastim SC on day 1 and placebo SC on
- Arm III: Patients receive filgrastim (G-CSF) SC on days 1-9.
- Leukapheresis: Patients undergo leukapheresis daily, beginning on day 5 until the
desired yield of CD34+ cells is obtained or a maximum of 5 leukaphereses is reached.
- Conditioning: Patients receive a myeloablative chemotherapy regimen as per
- Transplantation of PBPC: Approximately 1-3 days after completion of the conditioning
regimen, patients undergo reinfusion of autologous PBPC. Patients receive G-CSF SC
beginning on day of reinfusion and continuing until blood counts recover.
Patients are followed at 60 and 100 days.
PROJECTED ACCRUAL: A total of 90 patients (30 patients per treatment arm) will be accrued
for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Christos E. Emmanouilides, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|