enalidomide for Myelodysplastic Syndromes: Efficacy, Safety, Cardiac Changes, and Quality of Life (QoL-ESC RevMDS) - QoL-ESC RevMDS

ASSOCIAZIONE QOL-ONE0 个研究点开始时间: 2008年6月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Primary MDS
•2.Age ≥ 18 years
•3.Hb < 10 g/dL
•4.del(5q) as a single or associated (del(5q) +1 or more) bone marrow cytogenetic abnormality
•5.Low or Int-1 IPSS risk
•6.No evidence of other causes of anemia
•7.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

•1.Secondary MDS or evolving from prior hematological malignancies
•2.Intermediate-2 or High IPSS risk MDS
•3.Absolute neutrophil counts (ANC) < 500 cells/mm3
•4.Platelet counts < 50,000/mm3
•5.Contemporary epoetin treatment (epoetin treatment must be interrupted 4 months prior to screening)
•6.Prior chemotherapy
•7.Creatinine clearance < 60 ml/min
•8.Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) and serum direct bilirubin > 2.0 mg/dL
•9.Cardiac arrythmias.
•10.Thrombophilia or prior thomboembolic events in the absence of proper prophylactic treatment.
•11.Pregnancy or inadequate birth control in females of childbearing potential.

发起方

ASSOCIAZIONE QOL-ONE