Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia
- Determine the treatment-related mortality (TRM) rate at 100 days in patients with
hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing
nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors.
- Determine the TRM at 12 months in patients treated with this regimen.
- Determine the 6-month engraftment rate in patients treated with this regimen.
- Determine 1-year overall survival of patients treated with this regimen.
- Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes
on days -7 to -3, busulfan* IV over 6 hours on days -4 and -3, and anti-thymocyte
globulin IV over 6-10 hours on days -4 to -1.
NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to
-3 instead of busulfan.
- Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral
blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF)
subcutaneously daily beginning on day 7 and continuing until blood counts recover.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice
daily or IV continuously beginning on day -2 and continuing for approximately for 6-12
months after transplantation. Patients also receive mycophenolate mofetil orally or IV
twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11**.
NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day
- Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active
GVHD may receive DLI. A second DLI may be infused > 8 weeks after the first in the
absence of disease response or GVHD.
After completion of study treatment, patients are followed periodically for at least 2
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Charles A. Linker, MD
University of California, San Francisco
United States: Federal Government
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|