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

Ospedale Maggiore Di Trieste

Status: Unknown

Conditions: Acute Myeloid Leukemia, Adult; Hypomethylating Agents; Venetoclax

Treatments: Drug: Venetoclax

Study type: Observational

Funder types: Other

Identifiers

NCT04454580

HMA-V

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

treated patients

Description:

hypomethylating agent (azacitidine or decitabine) in combination with venetoclax

Treatment:

Drug: Venetoclax