Pilot study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients with Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia utilising conditioning with Fludarabine, Busulphan and Thymoglobuline

King's College Hospital NHS Foundation Trust0 个研究点开始时间: 2009年1月9日最近更新: 2017年8月21日

试验速览

暂无简介。

•1.Availability of a HLA compatible sibling donor
•2.Age >18 years
•3.Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
•4.Poor risk acute myeloid leukaemia, de novo or transformed from MDS
•5.Ineligibility for standard conditioning allograft due to age or co-existing morbidities
•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.Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
•2.Hepatic disease, with AST > 2 times normal.
•3.Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted.
•4.Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
•5.Patients who have received previous treatment with Thymoglobuline
•6.HIV-positive patients.
•7.Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
•8.Life expectancy severely limited by diseases other than MDS or MPD.
•9.Serious concurrent untreated infection
•10.Patients with limited life expectancy for other reasons
•11.Serious psychiatric/ psychological disorders
•12.Absence of /inability to provide informed consent

发起方