The purpose of this study is to determine the safety and feasibility of conditioning with fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML) undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible sibling donors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Fludarabine 30mg/m2 intravenously daily on days -9 to -5 inclusive of stem cell infusion.
Busulphan 0.8mg/kg intravenously 6 hourly on days -4 and -3 of stem cell infusion.
Thymoglobuline will be given intravenously over a minimum of 6 hours for the first two doses and 4 hours for the subsequent doses. Acute side effects of ATG appear to be reduced if a very low dose is given for the first injection. Thymoglobuline 0.5mg/kg iv on day -4, 1.5mg/kg/day on day -3; and 2mg/kg/day iv on day -2 to -1 inclusive.
The source of stem cells will be PBSC wherever possible. Patients whose donors decline or are unable to donate PBSC will be transplanted with marrow cells.
King's College Hospital NHS Foundation Trust
London, United Kingdom
Treatment related mortality to Day 100
Time frame: Days 28, 56 and 100
Incidence of single or multi-organ acute toxicity
Time frame: Days 28, 56 and 100
Incidence of graft failure/rejection
Time frame: Days 28, 56 and 100
Incidence of acute graft-versus-host disease
Time frame: Days 28, 56, 100 and months 6, 9, 12, 18 and 24
Incidence of systemic infections
Time frame: Days 28, 56, 100 and months 6, 9, 12, 18 and 24
EBV activation
Time frame: Fortnightly for first 6 weeks after transplantation and then weekly for the first 6 months.
Overall survival
Time frame: Days 28, 56, 100 and months 6, 9, 12, 18 and 24
Disease free survival/relapse risk
Time frame: Days 28, 56, 100 and months 6, 9, 12, 18 and 24
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