Spots Global Cancer Trial Database for Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

Official Title: Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy

Study ID: NCT00005787

Conditions

Lymphoma

Neutropenia

Interventions

epoetin alfa

filgrastim

recombinant flt3 ligand

recombinant interleukin-3

sargramostim

in vitro-treated peripheral blood stem cell transplantation

Study Description

Brief Summary: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant. PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.

Detailed Description: OBJECTIVES: * Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma. * Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy. * Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo. * Determine the relationships between length of culture, immunophenotype, and clinical outcome. * Determine the required numbers of white blood cell precursors for clinical efficacy. * Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period. OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0. Patients are followed monthly for 1 year. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.