Azacitidine compared to conventional chemotherapy in consolidation of elderly patients (> 65 years) with AML in first complete remission

The Swedish AML Group0 个研究点开始时间: 2012年9月20日最近更新: 2016年5月2日

适应症

试验速览

暂无简介。

•1. Subjects >=65 years of age at the time of signing the informed consent form
•2. A confirmed diagnosis of AML according to the 2008 WHO classification
•This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBPA
•Biobanking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank).
•3. A documented CR or CRp achieved after one or two induction courses.
•CR is defined as
•-bone marrow blasts < 5% with regenerating hematopoiesis
•-no extramedullary leukemia
•-independency of erythrocyte transfusions
•-neutrophils > 1.0 x 10(9)/L
•-platelets > 100 x 10(9)/L
•Criteria for complete remission with low platelet count (CRp):
•- A patient fulfilling bone marrow and peripheral blood criteria for CR in AML but who has a lower platelet count than 100 x 10(9) may also be considered CR (CRp) provided platelet count is stable and greater than 30 x 10(9) and there is no bleeding symptoms.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 130

•1. Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.
•2. Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.
•3. Patients with acute promyelocytic leukemia
•4. Patients with t(8;21) or inv(16)
•5. CNS leukemia
•6. Patients with a previous diagnosis of MDS, i.e. AML preceeded by a diagnosed MDS
•7. Subjects who are candidates for allogeneic stem cell transplantation (SCT)
•8. Another cancer diagnosis with a life expecancy of less than two years

发起方

The Swedish AML Group