Lymphoma Clinical Trial
Official title:
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy
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.
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.
;
Primary Purpose: Supportive Care
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