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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Karolinska University Hospital, Solna
Stockholm, Sweden
Leukemia free survival
Time frame: One year
Overall survival
Time frame: Two years
Treatment related morbidity and mortality
Time frame: Two years
Severe Adverse Events (SAE)
SAE as defined by CTCAE
Time frame: Two months after the last course of consolidation
Number of days admitted in hospital
Time frame: 12 months from start of consolidation treatment
Quality of life
EORTC QLQ C30
Time frame: Until 24 months from start of consolidation treatment
Number of participants with AE grade 3 or more
AE:s graded according to CTCAE
Time frame: Until two months after the last course of consolidation
Number of consolidation courses actually given within the study
Time frame: One year
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