A Study to Asses Effectiveness and Treatment Management of Oral Venetoclax Tablets + Subcutaneously Injected Azacitidine in Adult Participants Ineligible for Intensive Chemotherapy With de Novo Acute Myeloid Leukemia (AML) in Italy

Study Identifier
P23-498
CT.gov Identifier
NCT06058741
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities or any other clinical reason as defined by the treating physician. * Investigator decision on patient treatment with venetoclax + azacitidine must have been reached prior to and independently of recruitment in the study. * Treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
    Exclusion Criteria:
    * Participants affected by Acute Promyelocytic Leukemia. * Prior treatment for AML, excluding hydroxyurea. * Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another post-marketing observational study or Registry is acceptable

    Protocol Summary

    Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy.

    Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy.

    Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 months.

    There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 18 months.

    Study Locations

    Location
    Status
    Location
    Presidio Ospedaliero Vito Fazzi /ID# 261222
    Lecce, Apulia, Italy, 73100
    Status
    Not applicable
    Location
    Azienda Ospedaliero Universitaria Careggi /ID# 259766
    Florence, Firenze, Italy, 50134
    Status
    Not applicable
    Location
    Ospedale San Martino /ID# 258981
    Genoa, Genova, Italy, 16132
    Status
    Not applicable
    Location
    IRCCS Istituto Clinico Humanitas /ID# 259300
    Rozzano, Lombardy, Italy, 20089
    Status
    Not applicable
    Location
    ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833
    Busto Arsizio, Milano, Italy, 21052
    Status
    Not applicable
    Location
    ASST Grande Ospedale Metropolitano Niguarda /ID# 259455
    Milan, Milano, Italy, 20162
    Status
    Not applicable
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