?Clinical and biological effects of 5-Azacitidine five days/monthly schedule in symptomatic low-risk myelodysplastic syndromes (MDSs)? - MDS0706

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 个研究点开始时间: 2007年11月22日最近更新: 2012年3月19日

试验速览

暂无简介。

•Patients with low-risk (IPSS 0-INT1) MDS according to WHO classification, presenting one or more of the followings:
•-Symptomatic anemia requiring RBC transfusion supportive therapy previously unresponsive to EPO or not expected to respond to EPO,
•-Thrombocytopenia requiring platelet transfusion with or without muco-cutaneous haemorragic syndrome.
•Persistent (>3 months) absolute neutrophil count less then 1,5 x 109/L , with or without infections, requiring or not myeloid growth factor therapy.
•≥18 years old.
•Life expectancy≥3months.
•ECOG performance Status Grade 0-2.
•Serum bilirubin levels ≤1.5 upper limit of the normal (ULN)
•Serum GOT and GPT levels ≤ 2x UNL.
•Creatinine levels ≤1.5x UNL.
•Negative serum β-human chorionic gonadotropin (β-HCG) pregnancy test 24 hours prior to beginning of therapy with 5-AZA, for fertile women.
•Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with MDS according to WHO classification with INT-2 or high IPSS risk.
•Life expectancy < 3months;
•ECOG performance Status Grade > 2;
•Serum bilirubin levels >1.5 upper limit of the normal (ULN);
•Serum GOT and GPT levels > 2 x UNL;
•Creatinine levels >1.5 x UNL;
•Pregnancy or breast feeding
•Insulin-dependent diabetes and uncontrolled non insulin-dependent diabetes;
•Severe cardiac or pulmonary disease incompatible with the conduction of the protocol;
•Patient with a clear indication to receive long-term anticoagulant therapy;
•Other active hematologic or solid tumors;
•Severe CNS disease;
•Malignant hepatic tumors
•Hypersensitivity to mannitol or azacitidine
•No written informed consent.

发起方

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA