Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT

In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures.

The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.

Inclusion criteria

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Myeloproliferative Disorders
• Chronic Myeloid Leukemia

Exclusion criteria

• Performance status ECOG>2
• Cardiomyopathy (LVEF <39%)
• Pulmonary dysfunction (DLCO<39%)
• Hepatic dysfunction Grade >1
• Renal dysfunction Grade >1 (Creatinine > 1.6 mg/dl)
• HIV infection
• Other active neoplasm