NCT04454580

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Ospedale Maggiore Di Trieste · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Acute Myeloid Leukemia, Adult
• Hypomethylating Agents
• Venetoclax

Interventions

Type	Name	Description
DRUG	Venetoclax	treatment with azacitidine or decitabine in combination with venetoclax

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-09-16
• Completion: 2020-09-30
• First posted: 2020-07-01
• Last updated: 2020-09-16

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study