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

NCT ID: NCT06090786

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-07-31

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.

Conditions

AML, Adult; Minimal Residual Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MRD evaluation

Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax

Group Type: OTHER

MRD assessment

Intervention Type: DIAGNOSTIC_TEST

Bone marrow withdrawal for MRD quantification

Interventions

MRD assessment

Bone marrow withdrawal for MRD quantification

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Curti

Role: PRINCIPAL_INVESTIGATOR

Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna

Central Contacts

Paola Fazi

Role: CONTACT

p.fazi@gimema.it

0670390528

Enrico Crea

Role: CONTACT

e.crea@gimema.it

0670390514

Other Identifiers

AML2723

Identifier Type: -

Identifier Source: org_study_id