Treosulfan Based Conditioning Myelodysplastic Syndrome (MDS)

Inclusion criteria

• Patients with myelodysplastic syndrome, (MDS) according to WHO classification (< 20 % myeloblasts in peripheral blood or bone marrow at initial diagnosis) indicated for allogeneic transplantation
• Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) HLA-identity defined by the following markers: HLA-A, -B, -DRB1, DQB1.
• Target graft size (unmanipulated) bone marrow: 2 to 10 x 106 CD34+ cells/kg BW recipient or at least 2 x 108 nucleated cells /kg BW or peripheral blood: 4 to 10 x 106 CD34+ cells/kg BW recipient
• Age > 18 and < 60 years
• Karnofsky Index > 80 %
• Adequate contraception in female patients of child-bearing potential
• Written informed consent

Exclusion criteria

• 'Secondary' or therapy-related MDS with known history of exposure to cytotoxic alkylating drugs and/or radiation therapy
• Previous AML-induction therapy with more than two courses (e.g. in case of blast excess)
• Previous allogeneic transplantation
• Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function)
• Known and manifested malignant involvement of the CNS
• Active infectious disease
• HIV- positivity or active hepatitis infection
• Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit)
• Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
• Pleural effusion or ascites > 1.0 L
• Pregnancy or lactation
• Known hypersensitivity to treosulfan and/or fludarabine
• Participation in another experimental drug trial within 4 weeks before study
• Non-co-operative behaviour or non-compliance
• Psychiatric diseases or conditions that might impair the ability to give informed consent