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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06090786
Other study ID # AML2723
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date July 2027

Study information

Verified date April 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 225
Est. completion date July 2027
Est. primary completion date July 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MRD assessment
Bone marrow withdrawal for MRD quantification

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of MRD-negative patients within cycle 4 Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication 4 months
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