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

Primary Purpose

AML, Adult, Minimal Residual Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRD assessment
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for AML, Adult focused on measuring Venetoclax, Azacitidine, AML, Minimal rsidual disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    MRD evaluation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06090786
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2027 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    AML, Adult, Minimal Residual Disease
    Keywords
    Venetoclax, Azacitidine, AML, Minimal rsidual disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    225 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MRD evaluation
    Arm Type
    Other
    Arm Description
    Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    MRD assessment
    Intervention Description
    Bone marrow withdrawal for MRD quantification
    Primary Outcome Measure Information:
    Title
    Rate of MRD-negative patients within cycle 4
    Description
    Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paola Fazi
    Phone
    0670390528
    Email
    p.fazi@gimema.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Enrico Crea
    Phone
    0670390514
    Email
    e.crea@gimema.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio Curti
    Organizational Affiliation
    Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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