Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation
- Evaluate the incidence of graft acceptance in patients with hematological disorders
treated with combined immunosuppression before and after HLA-haploidentical
hematopoietic stem cell transplantation.
- Evaluate efficacy of this regimen in these patients.
- Evaluate toxicity of this regimen in these patients.
- Assess survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to
-1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1.
- Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on
day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF)
beginning on day 4 and continuing until blood counts recover.
- Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing
for 6 months and mycophenolate mofetil 4 times a day on days 4-84.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Incidence of graft acceptance
Didier Blaise, MD