A Pivotal Study to Determine the Safety and Efficacy of Using B-Cell High Density Microparticles (BCell-HDM) to Deplete B-Cells From Peripheral Blood Stem Cell Collections Without Compromising the Time to Neutrophil and Platelet Engraftment in Patients With Relapsed Low or Intermediate Grade B-Cell Non-Hodgkin's Lymphoma Given Autologous Peripheral Blood Stem Cell Transplants After High-Dose Chemotherapy
OBJECTIVES: I. Determine the effectiveness of the B-cell high density microparticles
(BCell-HDM) device in purging B-cells from peripheral blood stem cells (PBSC) harvested from
patients with relapsed low or intermediate grade B-cell non-Hodgkin's lymphoma. II.
Determine the recovery of T-cells and CD34+ cells in BCell-HDM processed PBSC in these
patients. III. Compare hematopoietic engraftment following infusion of autologous PBSC
purged using the BCell-HDM device versus unpurged autologous PBSC in these patients
receiving high dose chemotherapy. IV. Determine the toxicity of this regimen in these
patients. V. Determine the occurrence of adverse effects from this regimen in these
patients.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by
grade of lymphoma (low vs intermediate), type of myeloablative conditioning regimen
(chemotherapy only vs chemotherapy/total body irradiation), and center. Patients are
randomized to one of two treatment arms. Patients undergo peripheral blood stem cell (PBSC)
harvest over no more than 4 consecutive days. A myeloablative conditioning regimen of either
chemotherapy alone or chemotherapy/total body irradiation is given within 4 weeks of PBSC
harvest. Prior to randomization one patient at each center receives PBSC transplantation
using cells purged with the B-cell high density microparticle (BCell-HDM) device. Arm I:
Patients receive BCell-HDM treated PBSC transplantation on day 0. Arm II: Patients receive
untreated PBSC transplantation on day 0. Patients receive filgrastim (G-CSF) subcutaneously
beginning on day 1 and continuing until blood counts recover. Patients are followed on days
30 and 100, and then at 6 and 12 months.
PROJECTED ACCRUAL: A total of 115 patients (15 for prerandomization study, 50 for each
treatment arm) will be accrued for this study.
Interventional
Primary Purpose: Treatment
William I. Bensinger, MD
Study Chair
Fred Hutchinson Cancer Research Center
United States: Federal Government
1488.00
NCT00006241
March 2000
October 2000
Name | Location |
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Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |