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

• Conditions: Hypomethylating Agents; Venetoclax; Acute Myeloid Leukemia, Adult
• Interventions: Drug: Venetoclax

• Registration Number: NCT04454580
• Lead Sponsor: Ospedale Maggiore Di Trieste

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.

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-27
• Study First Posted: 2020-07-01
• Study Start: 2020-08-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Primary Completion: 2020-09-16
• Last Update Posted: 2020-09-16
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treated patients	Venetoclax	hypomethylating agent (azacitidine or decitabine) in combination with venetoclax

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rate	every three months after started treatment up to two years	according to European Leukemia Network (ELN)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	every three months after started treatment up to two years	according to European Leukemia Network (ELN)
Morphologic leukemia-free state (MLFS)	every three months after started treatment up to two years	according to European Leukemia Network (ELN)
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	from start of the treatment to progression or death
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	from start of the treatment to progression or death
adverse events and serious adverse events	through study completion, for an average of 1 year	according to CTCAE v. 4.0

Trial Locations

Locations (1)

SC Ematologia Ospedale Maggiore; 🇮🇹 Trieste, Italy