Treatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia

VU University medical center0 个研究点开始时间: 2013年4月9日最近更新: 2013年6月3日

适应症

试验速览

暂无简介。

•Patients with Acute Myeloid Leukemia according to WHO classification 2008
•Age 18-75
•Indication for allogeneic stem cell transplantation based on risk group profile
•Related or unrelated 8/8 HLA matched donor available
•Presence of Leukemia Associated Phenotype(s)
•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 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•-Myelodysplastic syndrome with refractory anaemia with excess blasts (RAEB)
•Acute Promyelocytic Leukemia (AML M3)
•-Absence of LAP(s)
•-Previous allogeneic stem cell transplantation
•-Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
•Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
•Severe neurological or psychiatric disease
•Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times upper limit of normal) unless related to treatment
•Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration)
•Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
•Patient known to be HIV-positive
•Pregnant or breast-feeding female patients
•Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

发起方

VU University medical center