Sequential FLAMSA chemotherapy and T cell depleted reduced intensity conditioning allogeneic stem cell transplantation (TCD FLAMSA-RIC alloSCT) in elderly acute myeloid leukemia and high risk myelodysplasia patients - FLAMSA-RIC alloSCT in elderly AML and high risk MDS patients

eiden Universtity Medical Center0 个研究点开始时间: 2014年4月3日最近更新: 2014年11月24日

适应症

试验速览

暂无简介。

•Patients with AML or high risk MDS (IPSS >= 1.5)
•Not in remission after first intensive induction chemotherapy (morphologically > 5% blasts in bone marrow aspirate)
•60-75 years, inclusive
•HLA-identical sibling or unrelated donor completely matched (10/10 for HLA A, B, C, DR, DQ)
•WHO-performance status 0-2 (see appendix A)
•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 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 11

•Previous autologous or allogeneic SCT
•Acute promyelocytic leukemia
•Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix B);
•Severe cardiac dysfunction (NYHA classification 3-4, see appendix C).
•Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times upper limit of normal);
•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.);
•Severe neurological or psychiatric disease;
•Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
•Patient known to be HIV-positive

发起方

eiden Universtity Medical Center