Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Low- or Intermediate-Grade Non-Hodgkin's Lymphoma
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Treating the peripheral stem cells in the laboratory to remove any existing cancer cells may improve the effectiveness of the transplant.
PURPOSE: Randomized phase II trial to compare the effectiveness of treated peripheral stem cells with that of untreated stem cells in patients who have relapsed low- or intermediate-grade non-Hodgkin's lymphoma.
|Lymphoma||Biological: filgrastim Drug: chemotherapy Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||March 2000|
|Study Completion Date:||October 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006241
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||William I. Bensinger, MD||Fred Hutchinson Cancer Research Center|