Dose-reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study (RICMAC)
- Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome
(MDS), either as
- refractory anaemia (RA) according FAB or RA with or without dysplasia according
- 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
- 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
- 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 anti¬gen-mismatch allowed):
- No major organ dysfunction.
- Written informed consent of the patient.
- 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
- Serious psychiatric or psychological disorders.
- Invasive fungal infection at time of registration.