Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Adult, Hypomethylating Agents, Venetoclax

Intervention / Treatment
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* Drug: Venetoclax


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treated patients<br>hypomethylating agent (azacitidine or decitabine) in combination with venetoclax | Drug: Venetoclax<br>* treatment with azacitidine or decitabine in combination with venetoclax<br>* Other names: Decitabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response (CR) rate | according to European Leukemia Network (ELN) | every three months after started treatment up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | according to European Leukemia Network (ELN) | every three months after started treatment up to two years | 
| Morphologic leukemia-free state (MLFS) | according to European Leukemia Network (ELN) | every three months after started treatment up to two years | 
| Progression-free-survival | from start of the treatment to progression or death | 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 | 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 | through study completion, for an average of 1 year |