This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Clofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C.
SC Ematologia-AO SS.Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
To assess the remission rate according to the combination regimen
Time frame: 19 months
Duration of response and survival
Time frame: 19 months
Time to transformation in AML
Time frame: 19 months
To determine the relationship of cytogenetic abnormalities and response to treatment
Time frame: 19 months
To determine the safety and tolerability of the combination regimen
Time frame: 19 months
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Ancona, Italy
Ematologia con trapianto-AO Policlinico Bari
Bari, Italy
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Brescia, Italy
centro di ricerca e di formazione ad alta tecnologia nelle Scienze-Università Cattolica Campobasso
Campobasso, Italy
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Catania, Italy
Dipartimento di medicina Interna-Università di genova
Genova, Italy
UO Ematologia Vito Fazzi
Lecce, Italy
SC Ematologia-Azienda Ospedaliero Papardo
Messina, Italy
UO Ematologia-Ospedale San gennaro-ASL1
Naples, Italy
...and 11 more locations