Retrospective, Observational, Monocentric Study to Assess Efficacy and Safety of the Combination of an Hypomethylating Agent in Combination With Venetoclax for Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy
Overview
- Phase
- N/A
- Intervention
- Venetoclax
- Conditions
- Acute Myeloid Leukemia, Adult
- Sponsor
- Ospedale Maggiore Di Trieste
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Complete response (CR) rate
- Last Updated
- 5 years ago
Overview
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.
Investigators
Francesco Zaja
Professor
Ospedale Maggiore Di Trieste
Eligibility Criteria
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
Arms & Interventions
treated patients
hypomethylating agent (azacitidine or decitabine) in combination with venetoclax
Intervention: Venetoclax
Outcomes
Primary Outcomes
Complete response (CR) rate
Time Frame: every three months after started treatment up to two years
according to European Leukemia Network (ELN)
Secondary Outcomes
- Overall response rate (ORR)(every three months after started treatment up to two years)
- Morphologic leukemia-free state (MLFS)(every three months after started treatment up to two years)
- 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)
- 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)
- adverse events and serious adverse events(through study completion, for an average of 1 year)