AML, Adult, Minimal Residual Disease
Conditions
Keywords
Venetoclax, Azacitidine, AML, Minimal rsidual disease
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.
Interventions
DIAGNOSTIC_TESTMRD assessment
Bone marrow withdrawal for MRD quantification
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactPaola Fazi
Backup ContactEnrico Crea
Outcome results
None listed