Randomized maintenance therapy with Azacitidine (Vidaza) in older patients (= 60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t). A phase III study. - HOVON 97 AM

HOVON Foundation0 个研究点目标入组 126 人开始时间: 2008年12月29日最近更新: 2013年7月22日

研究概览

暂无简介。

•1) Age 60 years or more
•2) Subjects with a cytopathologically confirmed diagnosis of
•(a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or
•(b) refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5
•Note: Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukaemia are eligible.
•3) Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy (this induction therapy can be according to HOVON81, HOVON92 or similar protocols. Of note: also patients who are treated according to one of these protocols but were not formally included in these studies are eligible for HOVON97)
•4) Hematological recovery, i.e. ANC ³ 0.5 x 109/l and platelets ³ 50 x 109/l
•5) WHO performance status <= 2
•6) 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 100

•1) Extramedullary disease
•2) Planned allogeneic hematopoietic cell transplantation
•3) Previous polycythaemia rubra vera
•4) Primary myelofibrosis
•5) Blast crisis of chronic myeloid leukemia
•6) AML-FAB type M3 or AML with cytogenetic abnormality t(15;17)
•7) Impaired hepatic or renal function as defined by:
•a) ALT and/or AST > 2.5 x normal value
•b) Bilirubin > 2 x normal value
•c) Serum creatinin > 2 x normal value (after adequate hydration)
•8) Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
•9) Cardiac dysfunction as defined by:
•a) Myocardial infarction within the last 6 months of study entry, or
•b) Reduced left ventricular function with an ejection fraction <50%
•c) Unstable angina
•d) Unstable cardiac arrhythmias

发起方

HOVON Foundation