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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06090786

Collaborator

(none)

225

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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:

kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques
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.

Condition or Disease	Intervention/Treatment	Phase
AML, Adult Minimal Residual Disease	Diagnostic Test: MRD assessment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: MRD evaluation Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax	Diagnostic Test: MRD assessment Bone marrow withdrawal for MRD quantification

Arm

Intervention/Treatment

Other: MRD evaluation

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

Diagnostic Test: MRD assessment

Bone marrow withdrawal for MRD quantification

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Principal Investigator: Antonio Curti, Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT06090786

Other Study ID Numbers:

AML2723

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto

Venetoclax

Azacitidine

AML

Minimal rsidual disease

Additional relevant MeSH terms:

Neoplasm, Residual

Study Results

No Results Posted as of Oct 19, 2023