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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04454580
Study type Observational
Source Ospedale Maggiore Di Trieste
Contact Francesco Zaja, Professor
Phone +390403992888
Email francesco.zaja@asugi.sanita.fvg.it
Status Recruiting
Phase
Start date August 1, 2020
Completion date September 30, 2020

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