T Cell-Reduced Unrelated Donor Allogeneic Peripheral Blood Stem Cell Transplantation With Pentostatin and Low-Dose Total Body Irradiation
OBJECTIVES:
Primary
- To determine the safety of pentostatin and low-dose total body irradiation followed by
T-cell-reduced unrelated donor peripheral blood stem cell transplantation, in terms of
regimen-related toxicity, in patients with hematological malignancies.
- To evaluate the efficacy of this regimen, measured as engraftment rate and
establishment of donor hematopoietic chimerism, in these patients.
Secondary
- To determine the incidence of acute and chronic graft-versus-host disease in patients
treated with this regimen.
OUTLINE:
- Reduced-intensity preparative regimen: Patients receive pentostatin IV over 30 minutes
once daily on days -10 to -8 and undergo low-dose total-body irradiation on day -1.
- Unrelated donor peripheral blood stem cell transplantation (PBSCT): Patients undergo
T-cell-reduced donor PBSCT on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2
hours twice daily on days -1, 0, and 1 and then orally twice daily on days 2-70
followed by a taper in the absence of GVHD. Patients also receive oral mycophenolate
mofetil twice daily on days 0-27 followed by a taper.
Patients undergo bone marrow aspirate and biopsies and blood sample collection periodically
for laboratory studies. Samples are analyzed for cytokines (i.e., IL-6, TNF-γ, IL-1β, and
IL-10) by ELISA; phenotypic, molecular, and functional analysis of immunologic
reconstitution markers (i.e., PHA, IL-2, IL-4, IL-10, IL-12, Fas, FasL, TNF, TGF-β, and
IFN-γ) by flow cytometry; and cytogenetics by FISH.
After completion of study treatment, patients are followed periodically.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Severe transplant-related toxicity (grade III-IV adverse events) as assessed by NCI CTCAE v2.0
before day 100
Yes
Robert Bociek, MD
Principal Investigator
University of Nebraska
United States: Institutional Review Board
164-07
NCT00816413
September 2008
February 2010
Name | Location |
---|---|
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |