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NCT Number: NCT05587049

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Pablo Tobón Uribe /ID# 248569, Medellín, Antioquia, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 18 months

    OS defined as the time from the date of start Venetoclax to the date of death from any cause.

Secondary outcomes

  1. Percentage of Participants Achieving Complete Remission (CR)

    Time frame: Up to 18 Months

    CR is defined according to the modified International Working Group (IWG) criteria for acute myeloid leukemia (AML) as no morphologic evidence of AML and absolute neutrophil count >=10^3 /μL (>=1.0 x 10^9 /L), platelets >=10^5 /μL (>=100 x 10^9 /L), red blood cell (RBC) transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

  2. Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (Cri)

    Time frame: Up to 18 Months

    Cri is defined according to the modified IWG criteria for AML as all criteria as CR except for residual neutropenia <10^3 /μL (1,000/ μL), or thrombocytopenia <10^5 /μL (100,000/ μL). If all criteria for CR are meet except for RBC transfusion independence, this also fulfills Cri criteria.

  3. Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (CRh)

    Time frame: Up to 18 Months

    CRh is defined according to the modified IWG criteria for AML as bone marrow with < 5% blasts and Peripheral blood neutrophil count of > 0.5 × 10^3 /μL and Peripheral blood platelet count of > 0.5 × 10^5 /μL and 1-week (>= 7 days) platelet transfusion-free period prior to the hematology lab collection.

  4. Percentage of Participants Achieving Transfusion Independence

    Time frame: Up to 18 Months

    Transfusion ndependence is defined as a period of at least 56 days with no transfusion between the first dose of Venetoclax and the last dose of Venetoclax plus 30 days.

  5. Event-Free Survival (EFS)

    Time frame: Up to 18 Months

    EFS defined as the time from the date of start Venetoclax to the date of morphologic relapse, progressive disease, resistant disease, treatment failure, or death from any cause.

  6. Duration of Remission (DOR)

    Time frame: Up to 18 Months

    DOR defined as the time from the date of first CR, CRi or CRh to the earliest evidence of morphologic relapse, progressive disease, or death due to disease progression.

  7. Duration of Treatment (DoT)

    Time frame: Up to 18 Months

    DoT defined as the time from the start of a therapy to the time of treatment discontinuation for any reason.

  8. Percentage of participants with Adverse Events (AE)

    Time frame: Up to 18 Months

    AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product.

  9. Percentage of participants achieving Minimal Residual Disease (MRD) negativity

    Time frame: Up to 18 Months

    MRD negativity, defined as having less than 10^-3 residual blasts per leukocyte measured in the bone marrow.

  10. Change in Health-Related Quality of Life (HRQOL) Score

    Time frame: Up to 18 Months

    HRQOL score, defined as a multidimensional construct defined as the subjective perception of the life as a whole, including physical, emotional, social, cognitive functions, disease symptoms and side effects of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Duarte

CONTACT

[email protected]

+57 1 638-5000

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice

Acronym: ESVECO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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