The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.
Conditioning therapy * 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 * Donor * 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 GVHD prophylaxis * 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 d+60. * 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
Study Type
OBSERVATIONAL
Enrollment
20
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea
RECRUITINGrelapse 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.
Time frame: 4years
engraftment, donor chimerism, secondary graft failure,GVHD
•This study will evaluate engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, non-relapse mortality, progression-free survival (PFS), and OS.
Time frame: 4 years
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