Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study
Inclusion Criteria:
- Disease: cytologically proven
- primary or therapy related myelodysplastic syndrome (MDS) either as
- refractory anaemia (RA) according FAB or RA with or without dysplasia
according WHO
- refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with
or without dysplasia according WHO
- refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or
RAEB II according WHO
- refractory anaemia with excess of blast in transformation (RAEB-T)
according FAB
- CMML (dysplastic type) according WHO
- or secondary acute myeloid leukaemia (sAML)
- Blast count <20 percent in bone marrow with or without chemotherapy at time of
transplantation
- Patient eligible for standard and dose-reduced conditioning as per local guideline
- Patient age 18-60 years if donor is a HLA-matched UNRELATED donor (HLA-A, HLA-B,
HLA-DRB1 and HLA-DQB1) (one mismatch allowed)
- Patient age 18-65 years if donor is a HLA-matched RELATED donor (HLA-A, HLA-B,
HLA-DRB1 and HLA-DQB1)(one antigen-mismatch allowed)
- no major organ dysfunction
- written informed consent of the patient
Exclusion Criteria:
- Blasts >20% in bone marrow at time of transplantation
- no written informed consent
- central nervous involvement
- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- total bilirubin, SGPT or SGOT > 2 times upper the normal level
- Left ventricular ejection fraction <30%
- creatinine clearance <30 ml/min
- DLCO <35% and/or receiving supplementary continuous oxygen
- Positive serology for HIV
- pregnant or lactating women
- patients with a life-expectancy of less than six months because of another
debilitating disease
- serious psychiatric or psychological disorders
- invasive fungal infection at time of registration