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

Not Applicable

Not yet recruiting

• Conditions: Minimal Residual Disease; AML, Adult
• Interventions: Diagnostic Test: MRD assessment

• Registration Number: NCT06090786
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Study Start: 2024-07
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Subject must be ≥ 18 years of age
• Subject has diagnosis of AML according to WHO 2016
• Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)
• Subject is planned to receive front-line therapy with Azacitidine and Venetoclax
• Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice
• Subject must have assessable MRD by flow cytometry at screening BM evaluation
• Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion Criteria

• Diagnosis of BCR::ABL1-positive AML
• Diagnosis of APL
• AML with CNS involvement.
• AML with extra-medullary localizations
• Patients' unwillingness or inability to comply with the protocol requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRD evaluation	MRD assessment	Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax

Primary Outcome Measures

Name	Time	Method
Rate of MRD-negative patients within cycle 4	4 months	Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication