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.
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
Diagnosis of BCR::ABL1-positive AML
Diagnosis of APL
AML with CNS involvement.
AML with extra-medullary localizations
Single group
MRD assessment
Diagnostic testBone marrow withdrawal for MRD quantification
Rate of MRD-negative patients within cycle 4
Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication
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This trial is not recruiting at the moment. You can still explore other options:
