A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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).
OUTLINE:
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.
Interventional
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
No
Ajay Gopal
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
7176
NCT01110135
August 2010
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |