This is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for intensive chemotherapy
The prognosis of acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy is poor (Kantarjian et al). Hypomethylating agents, azacitidine and decitabine, are effective and less toxic regimens, and treatment with these agents has improved the prognosis of these patients (Fenaux et al). Venetoclax, a Bcl-2 inhibitor, in combination with azacitidine has shown efficacy in AML patients with complete remission rate of 73% and overall survival at 2 years of 40-50% (Di Nardo et al). On these grounds, the aim of this study is to collect the real-life experience with this combination in previously untreated AML patients.
Study Type
OBSERVATIONAL
Enrollment
15
treatment with azacitidine or decitabine in combination with venetoclax
SC Ematologia Ospedale Maggiore
Trieste, Italy
RECRUITINGComplete response (CR) rate
according to European Leukemia Network (ELN)
Time frame: every three months after started treatment up to two years
Overall response rate (ORR)
according to European Leukemia Network (ELN)
Time frame: every three months after started treatment up to two years
Morphologic leukemia-free state (MLFS)
according to European Leukemia Network (ELN)
Time frame: every three months after started treatment up to two years
Progression-free-survival
from start of the treatment to progression or death
Time frame: from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years
Overall survival
from start of the treatment to progression or death
Time frame: from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years
adverse events and serious adverse events
according to CTCAE v. 4.0
Time frame: through study completion, for an average of 1 year
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