Lymphoma Clinical Trial
Official title:
Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies
RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace
immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell
transplantation in treating patients who have hematologic cancer.
OBJECTIVES:
- Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched
peripheral blood stem cells in patients with hematologic malignancies undergoing
allogeneic transplantation.
- Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment,
infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in
this patient population.
OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow
with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours
on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also
receive G-CSF subcutaneously daily until blood counts recover.
Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5
years.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.
;
Primary Purpose: Supportive Care
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