Dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation in patients with MDS or sAML: A randomised phase III study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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 50 – 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 the upper 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The present study will be a multicenter, prospective phase III-study comparing dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.;Secondary Objective: ;Primary end point(s): 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 Outcome Measures

Name	Time	Method

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