Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRD assessment.
- Who it may be relevant to
- Registry conditions: AML, Adult, Minimal Residual Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax
Overview
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 test MRD assessment
Bone marrow withdrawal for MRD quantification
Primary outcome measures
- Rate of MRD-negative patients within cycle 4 [Time frame: 4 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06090786 · AML2723