Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
- Busulfan 3.2 mg/kg/d on d-7 to -6
- Fludarabine 30 mg/m2 on d-7 to -2
- ATG 1.5-3.0 mg/kg/d on d-3 to -1
- Methylpred 2 mg/kg/d on d-4 to -1
Mobilization and harvest
- G-CSF 10 mcg/kg/d s.c. on d-3 to 0
- Harvest of PBMCs on d 0 to +1
Infuse G-PBMCs on d 0 to d+1.
- Donor G-PBMC infusion
- Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with
twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and
- Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7
Prophylactic dose-escalating DLIs
- Begin at d+120 or at least 2 wks after IST discontinuation.
- No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels
Observational Model: Case-Only, Time Perspective: Prospective
relapse incidence,duration of remission
The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.
Je-Hwan Lee, Doctor
Asan Medical Center
Korea: Food and Drug Administration