Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia
- Determine the safety of a preparative regimen comprising total body irradiation,
cyclophosphamide, thiotepa, and fludarabine, but without anti-thymocyte globulin, in
patients with high-risk leukemia treated with peripheral blood stem cell
transplantation from partially matched related donors.
- Determine the incidence of graft failure, acute graft-versus-host disease (GVHD), and
treatment-related mortality in patients treated with this regimen.
- Determine rates of chronic GVHD and relapse in patients treated with this regimen.
- Determine disease-free and overall survival in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive a preparative regimen comprising total lymphoid irradiation once daily on
days -13 to -11; cyclophosphamide IV over 1 hour on days -8 and -7; thiotepa IV over 4 hours
every 12 hours on day -6; fludarabine IV over 30 minutes on days -5 to -1; and total body
irradiation once on day -1. Patients also receive cyclosporine IV over 12 hours on days -8
to -1 and methylprednisolone IV twice daily on days -3 and -2. Patients receive
CD34-enriched T-cell-depleted allogeneic stem cell infusion on day 0.
Patients with disease progression or uncontrolled infection but without grade II or greater
graft-versus-host disease may receive up to 3 donor lymphocyte infusions at least 4 weeks
apart until disease regression.
Patients are followed at least weekly until day 100 and then at 6, 12, 18, 24, 36, and 48
PROJECTED ACCRUAL: A total of 20-51 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Incidence of graft failure 100 days post-transplant
Bipin N. Savani, MD
National Heart, Lung, and Blood Institute (NHLBI)
|NIH - Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892-1182|