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.
This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who
will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or
PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone
marrow (where blood cells are made) and cause very low blood counts. A collection of stem
cells (very young blood cells) followed by reinfusion to restore blood counts will be done
to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving
growth factors to patients is a method to increase the number of PBPC that can be collected
during leukapheresis. This process of giving growth factors to patients is called
mobilization (moving cells from the bone marrow to the peripheral blood where they can be
collected). The purpose of this study is to determine if pegfilgrastim, an investigational
drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or
G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified
version of Filgrastim that is longer acting.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
CD34+ collection during the collection phase
10 days
No
MD
Study Director
Amgen
United States: Food and Drug Administration
20020112
NCT00066092
April 2003
October 2004
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