A Phase I/II Study of Combined Enrichment of CD34+ Cells and Depletion of B-Cells From Peripheral Blood Stem Cell Components for Patients With B-Lymphoid Malignancies
OBJECTIVES: I. Evaluate the efficiency of tumor cell removal by immunomagnetic technique in
patients with B cell malignancies. II. Determine toxicity of mobilized peripheral blood stem
cell (PBSC) components of enriched CD34+ and depleted B cells in this patient population.
III. Compare recovery with the use of this treatment regimen to the use of unmanipulated
PBSC or CD34+ PBSC components in this patient population.
OUTLINE: Patients are assigned to one of two treatment arms for chemotherapy (chemotherapy
protocol following FHCRC-506.2). Patients undergo mobilization and isolation of CD34+ cells
as described in FHCRC-506.2. Peripheral blood stem cells are collected by apheresis and the
CD34+ cells are isolated using magnetic beads. Monoclonal antibodies to CD19 and CD20 are
added to the CD34+ cells to sensitize any remaining tumor cells. Patients undergo
transplantation on day 0, according to applicable transplant protocols, one month after
mobilization. Some patients may receive posttransplant interleukin-2 after achieving durable
engraftment. Patients are followed at day 30, 80, 180, 365, and 395.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.
Primary Purpose: Treatment
Scott D. Rowley, MD, FACP
Hackensack University Medical Center Cancer Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|