A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)
I. To estimate the frequency of bendamustine (bendamustine hydrochloride) combined with GCSF
(filgrastim) and dexamethasone to successfully mobilize peripheral blood stem cells (PBSCs)
(as determined by collecting a minimum of 2 x 10^6 cluster of differentiation (CD)34+/kg).
I. To evaluate the response rate to bendamustine by diagnosis using established
disease-specific response criteria.
II. To examine the number of apheresis cycles required to collect a minimum of 2 x 10^6
CD34+ cells/kg and ideally >= 5 x 10^6 CD34+ cells/kg (when achievable).
III. To assess the impact of bendamustine on B and T-lymphocyte populations in the
peripheral blood (CD20+ cells, natural killer [NK] cells, CD4+25+ foxP3- regulatory cells,
and CD8 cells).
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1
and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone orally (PO) on days 1-4,
and filgrastim subcutaneously (SC) beginning on day 5 and continuing until peripheral blood
stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3
days or until > 5 x 10^6 CD34+/kg has been collected.
After completion of study treatment, patients are followed for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Successful mobilization and collection of PBSCs
Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.
Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|