FLAT-Auto is a phase II trial. fludarabine and ARA-C will be combined with the alkylating agent treosulfan (FLAT), to investigate the feasibility and the efficacy of a new regimen, supported with autologous peripheral blood SCT (PBSCT), as final postremission consolidation in AML/MDS elderly patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Fludarabine i.v. 30 mg/m²/d day -6 to -2
Cytarabine i.v. 2 g/m²/d day -6 to -2
Treosulfan i.v. 10 g/m²/d day -6 to -4
Ospedale San Raffaele
Milan, Lombardy, Italy
Evaluation of disease free survival from first Complete Remission (CR)
Evaluation of disease-free survival (DFS) duration from documented first CR of AML or MDS with intermediate 2 or high IPSS (International Prognostic Score System).
Time frame: 2 years after transplantation
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Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood) Pegylated-Filgrastim s.c. 6 mg day +3