A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia

Study Identifier
P23-469
CT.gov Identifier
NCT05587049
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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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:
    * Newly diagnosed acute myeloid leukemia (AML) defined as participants that have histological confirmation of AML (de novo, secondary) by World Health Organization (WHO) criteria, and have not received any prior treatment for AML. * Ineligible to intensive chemotherapy due to \>=75 years of age; or \>=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy. * Participants starting treatment with venetoclax in combination with azacytidine treated according to the Colombia label and who are not completed the first cycle (Cycle 28 days).
    Exclusion Criteria:
    \- Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.

    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 adult participants in Colombia.

    Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia (AML). 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 70 participants will be enrolled in the study in Colombia.

    Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) or intravenous (IV) injection according to the approved local label. The duration of the study is approximately 36 months.

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

    Study Locations

    Location
    Status
    Location
    Hospital Pablo Tobón Uribe /ID# 248569
    Medellín, Antioquia, Colombia, 050034
    Status
    Recruiting
    Location
    Hospital Alma Mater de Antioquia /ID# 248562
    Medellin, Bogota D.C., Colombia, 50010
    Status
    Active, Not Recruiting
    Location
    Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
    Valledupar, Cesar Department, Colombia, 200001
    Status
    Recruiting
    Location
    Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
    Bogota DC, Cundinamarca, Colombia, 111221
    Status
    Active, Not Recruiting
    Location
    Clinica del Country /ID# 248430
    Bogota, Cundinamarca, Colombia, 110231
    Status
    Recruiting
    Location
    Fundación Santa Fé De Bogotá /ID# 248563
    Bogotá, Cundinamarca, Colombia, 110111
    Status
    Recruiting
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