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

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

NCT ID: NCT06090786

Condition: AML, Adult
Minimal Residual Disease

Conditions: Official terms:
Neoplasm, Residual

Conditions: Keywords:
Venetoclax
Azacitidine
AML
Minimal rsidual disease

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: MRD assessment
Description: Bone marrow withdrawal for MRD quantification
Arm group label: MRD evaluation

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: July 2024

Completion date: July 2027

Lead sponsor:
Agency: Gruppo Italiano Malattie EMatologiche dell'Adulto
Agency class: Other

Source: Gruppo Italiano Malattie EMatologiche dell'Adulto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06090786