Acute Myeloid Leukemia, Adult, Hypomethylating Agents, Venetoclax
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGVenetoclax
treatment with azacitidine or decitabine in combination with venetoclax
Sponsors
Ospedale Maggiore Di Trieste
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* age ≥18 years * newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy
Exclusion criteria
* promyelocytic acute myeloid leukemia * patients who have already received one or more prior lines of therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response (CR) rate | every three months after started treatment up to two years | according to European Leukemia Network (ELN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | every three months after started treatment up to two years | according to European Leukemia Network (ELN) |
| Morphologic leukemia-free state (MLFS) | every three months after started treatment up to two years | according to European Leukemia Network (ELN) |
| Progression-free-survival | from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years | from start of the treatment to progression or death |
| Overall survival | from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years | from start of the treatment to progression or death |
| adverse events and serious adverse events | through study completion, for an average of 1 year | according to CTCAE v. 4.0 |
Countries
Italy
Contacts
Primary ContactFrancesco Zaja, Professor
Outcome results
None listed