Peripheral Blood Stem Cell Allotransplantation for Hematological Malignancies Using a Positive Stem Cell Selection Technique for T-Cell Depletion, Followed by Delayed T-Cell Add-Back
- Determine the overall survival rate at day 200 in patients with hematologic cancers or
other diseases who undergo allogeneic peripheral blood stem cell transplantation using
the CliniMACS® CD34 Reagent System for T-cell depletion followed by delayed T-cell
- Determine the safety of this regimen, in terms of the nonrelapse mortality rate at day
200, in these patients.
- Myeloablative preparative regimen: Patients receive fludarabine phosphate IV over 30
minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2.
Patients also undergo high-dose* total body irradiation (TBI) twice daily on days -7 to
NOTE: *Patients over 55 years of age receive reduced-dose TBI.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients receive
T-cell-depleted (via the CliniMACS® CD34 Reagent System), filgrastim (G-CSF)-mobilized,
donor PBSC IV over 4 hours on day 0.
- Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine (or
tacrolimus) IV or orally twice daily on days -6 to 21, and then again beginning on day
89 and continuing up to day 150, followed by a slow taper to day 180, in the absence of
- Donor lymphocyte infusion (DLI): Patients receive delayed T-cell add-backs of donor
lymphocytes IV over 1 hour on day 90. If relapse occurs, patients may receive DLI
before day 90 or as a repeat infusion.
After completion of study therapy, patients are followed periodically for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Overall survival at day 200
Aarthi Shenoy, MD
National Heart, Lung, and Blood Institute (NHLBI)
|NIH - Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892-1182|