Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML

Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission

The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.

Inclusion Criteria:

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 CEBP A
   • Bio-banking 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.

Exclusion Criteria:

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 preceded by a diagnosed MDS
7. Subjects who are candidates for allogeneic stem cell transplantation (SCT)
8. Another cancer diagnosis with a life expectancy of less than two years