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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Diagnosis of BCR::ABL1-positive AML

Diagnosis of APL

AML with CNS involvement.

AML with extra-medullary localizations

Trial design

Treatments tested in this trial

  • MRD assessment

Treatment groups

225 Participants
are divided into 1 treatment group

Locations

This trial has no locations