Myelodysplastic Syndrome and secondairy Acute Myeloid Leukaemia
Conditions
Interventions
Arm A (standard conditioning):
Busulfan 4 mg/kg/day orally during 4 days or Busilvex 3.2 mg/kg/day
intravenously. during 4 days.
Cyclophosphamide 60 mg/kg/day intravenously during 2 days
Arm B (redu
Sponsors
European Group for Blood and Marrow Transplantation (EBMT) tav Prof. Dr. T. de Witte
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Cytogenetically proven MDS or sAML Patient between 18 and 60 years of age in case of a HLA matched unrelated donor Patient between 50 and 65 years of age in case of a HLA matched related donor
Exclusion criteria
Exclusion criteria: Blasts >20% in bone marrow at time of transplantation Patients with a life-expectancy of less than six months because of another debilitating disease Invasive fungal infection at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hypothesis is that a dose-reduced conditioning will reduce the non-relapse mortality from 40 % to 20 % at one year after allogeneic stem cell transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of haematopoietic recovery by day +30 post transplant between two arms. * Comparison of toxicity of both regimens. * Incidence of acute GVHD by day +100 and of chronic GVHD by day +365. * Overall survival and event-free survival post-transplant at two years. * Incidence of relapse post-transplant at two years. * Comparison of VOD (veno-occlusive disease0 between the two arms. * Comparison of infectious complications at one year and at two years after transplantation. * Comparison of quality of life between the treatment arms. | — |
Countries
Netherlands
Outcome results
None listed