Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax
AML, Adult, Minimal Residual Disease
About this trial
This is an interventional other trial for AML, Adult focused on measuring Venetoclax, Azacitidine, AML, Minimal rsidual disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Other
MRD evaluation
Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax