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) - HOVON 97 AM

HOVO0 个研究点目标入组 86 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Age 60 years or more
•- Subjects with a cytopathologically confirmed diagnosis of
•(a) AML (M0-M2 and M4-M7, FAB classification)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.
•- Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy
•- Hematological recovery, i.e. ANC >= 0.5 x 109/l and platelets >= 50 x 109/l
•- WHO performance status <= 2
•- Written informed consent

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

发起方

HOVO