Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity

The aim of this study is to test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.

Inclusion Criteria:

• Patients planned to undergo an allogeneic HSCT with myeloablative conditioning
• Age 18 - 65 years
• Myeloid leukemia respectively related precursor neoplasms (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome), or lymphoid neoplasms (acute lymphoblastic leukemia/lymphoma, mature B-/T-/natural killer (NK)-cell neoplasms).
• Human Leukocyte Antigen (HLA)-identical sibling donor or matched unrelated (min. 10/10 Ag matched)
• Patients with a history of hepatitis might be included, if no contraindication for HSCT exists.
• Patient must give written informed consent

Exclusion Criteria:

• Indication other than myeloid leukemia respectively related precursor neoplasms, or lymphoid neoplasms.
• Severe liver damage for > 2 weeks (bilirubin > 3xupper limit normal (ULN) or ASAT/ALAT > 5xULN)
• HIV infection
• Donor other than HLA-identical sibling or min. 10/10 matched unrelated donor
• Pregnant or lactating women
• Lack of written informed consent