Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases
- Determine the feasibility (i.e., risk of treatment-related mortality during the first 6
months after transplantation) of administering reduced-intensity allogeneic
hematopoietic stem cell transplantation to patients with hematologic cancer or other
- Determine the response rate (partial and complete response), 6- and 12-month
probabilities of response, and time to progression in patients treated with this
- Determine the risk of acute and chronic graft-versus-host disease in patients treated
with this regimen.
- Determine other toxicities of this regimen in these patients.
- Determine the overall survival and disease-free survival of patients treated with this
- Determine the impact of iron status on overall and disease-free survival.
- Determine the influence of quality of life (at time of transplantation) on overall
- Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days
-7 to -3. Patients also receive busulfan IV over 2 hours every 6 hours on days -4 and
-3 or melphalan IV over 2 hours on day -3.
- Graft-versus-host disease (GVHD) prophylaxis: Patients with matched related donors
receive oral tacrolimus twice daily on days -1 to 90 followed by a taper until day 180.
Patients also receive methotrexate IV on days 1, 3, and 6. Patients with matched
unrelated and 9/10 matched related donors receive oral tacrolimus twice daily on days
-1 to 180 followed by a taper; methotrexate IV on days 1, 3, 6, and 11; and oral
mycophenolate mofetil twice daily on days -2 to 60 followed by a taper. All patients
also receive antithymocyte globulin IV over 4 to 6 hours once a day on days -4 to -1.
- Allogeneic stem cell transplantation: Patients undergo allogeneic peripheral blood stem
cell transplantation or bone marrow transplantation on day 0. Patients receive
filgrastim (G-CSF) beginning on day 7 and continuing until blood counts recover.
- Lymphocyte infusion: Patients with progressive or stable disease while off
immunosuppression and no active GVHD may receive up to 3 donor lymphocyte infusions
from the original donor at 8-week intervals beginning on day 180 or 210 .
Quality of life is assessed at baseline.
After completion of study therapy, patients are followed every 3 months for 2 years and then
every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality within the first 6 months after transplantation
David Hurd, MD
Wake Forest University Baptist Medical Center
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|