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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Not yet enrolling

Conditions: AML, Adult; Minimal Residual Disease

Treatments: Diagnostic Test: MRD assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06090786

AML2723

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 1 patient group

MRD evaluation

Other group

Description:

Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax

Treatment:

Diagnostic Test: MRD assessment