NCT06090786

Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax

A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice. The main questions it aims to answer are: 1. kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques 2. impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.

Detailed description

This is a multicentric biological study at evaluating MRD kinetics during treatment with Azacitidine and Venetoclax as well as the impact of MRD on survival outcomes. Newly diagnosed, previously untreated, patients with AML, including de novo, secondary and therapy-related, receiving front-line therapy with Azacitidine and Venetoclax according to clinical practice will be included. Response assessment will be performed on BM aspirate according to ELN2022 response criteria. MRD evaluation will be performed on BM at pre-defined time-points during treatment. MRD assessment will be performed centrally in order to harmonize response evaluation.

Conditions

• AML, Adult
• Minimal Residual Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRD assessment	Bone marrow withdrawal for MRD quantification

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2023-10-19
• Last updated: 2024-04-10