Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders
Conditions
Keywords
Allogeneic HSCT, Busulfan, Fludarabina
Brief summary
Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.
Detailed description
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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