Trial Information

Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.

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.