Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
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.
|Lymphoma Neutropenia||Biological: epoetin alfa Biological: filgrastim Biological: recombinant flt3 ligand Biological: recombinant interleukin-3 Biological: sargramostim Procedure: in vitro-treated peripheral blood stem cell transplantation||Phase 1|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy|
|Study Start Date:||September 1999|
|Study Completion Date:||January 2002|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005787
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Jane N. Winter, MD||Robert H. Lurie Cancer Center|