Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS)

Overview

To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).

Conditioning therapy * Cytoxan 50 mg/kg/d on d-3 to -2 * Fludarabine 30 mg/m2 on d-6 to -2 * Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT) * Methylpd 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 Donor G PBMC infusion * Infuse G-PBMCs on d 0 to d+1. 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 Preemptive dose-escalating DLIs * Begin at d+120 or at least 2 wks after IST discontinuation. * Failure to achieve full donor chimerism No evidence of GVHD * CD3+ cell dose increment q 4 wks -+ cell dose: HLA-matched donor HCT (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), HLA-matched unrelated donor HCT (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), HLA-matched familial donor HCT (1 x 105/kg, 5 x 105/kg, 1 x 106/kg)

Conditions

Eligibility

Locations (1)

Outcomes

Central Contacts