Clinical trial NCT06090786: Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: AML, Adult
Minimal Residual Disease
Keywords: Venetoclax
Azacitidine
AML
Minimal rsidual disease
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Rate of MRD-negative patients within cycle 4
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Antonio Curti
role: PRINCIPAL_INVESTIGATOR
References: