Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Low- or Intermediate-Grade Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): filgrastim; chemotherapy; in vitro-treated peripheral blood stem cell transplantation; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Lenograstim
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma