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Acute Myeloid LeukemiaESVECONCT05587049

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

An observational study of Acute Myeloid Leukemia, run by AbbVie at 8 sites in Colombia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
How many people
70 participants
Where
8 sitesColombia
Study dates
30 Nov 2023to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Newly diagnosed AML participants who are ineligible to intensive chemotherapy, that starting treatment with Venetoclax in combination with azacytidine treated according to the Colombia label.

Who may be able to join

  • 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).

Who cannot join

  • Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Duarte contact

+57 1 638-5000

angela.duarte@abbvie.com

8 sites in 1 country

Colombia8 sites, 2 recruiting

  • Fundacion Santa Fe De Bogota /ID# 248563

    Bogota, Cundinamarca, 110111

    Recruiting

  • Clinica del Country /ID# 248430

    Bogota, Cundinamarca, 110231

    Recruiting

  • Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570

    Bogota DC, Cundinamarca, 111221

    Active, not recruiting

  • Fundacion Valle Del Lili /ID# 248294

    Cali, Valle del Cauca Department, 760016

    Active, not recruiting

  • FOSCAL International /ID# 287252

    Floridablanca, Santander Department, 681004

    Active, not recruiting

  • Hospital Alma Mater de Antioquia /ID# 248562

    Medellin, Bogota D.C., 50010

    Active, not recruiting

  • Hospital Pablo Tobon Uribe /ID# 248569

    Medellín, Antioquia, 050034

    Active, not recruiting

  • Sociedad de Oncologia y Hematologia del Cesar /ID# 248615

    Valledupar, Cesar Department, 200001

    Completed

Other trials in Colombia

About this study

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

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.

Read more

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.

Keywords
Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, Azacitidine, ABT-199, Cancer
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05587049
Study groupRoleWhat they receive
Venetoclax + Azacitidine ParticipantsParticipants treated with venetoclax in combination with azacitidine in accordance with approved local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: Up to 18 months

Secondary outcomes (10)

  1. Percentage of Participants Achieving Complete Remission (CR)

    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.

    Measured: Up to 18 Months

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

    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.

    Measured: Up to 18 Months

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

    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.

    Measured: Up to 18 Months

  4. Percentage of Participants Achieving Transfusion Independence

    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.

    Measured: Up to 18 Months

  5. Event-Free Survival (EFS)

    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.

    Measured: Up to 18 Months

  6. Duration of Remission (DOR)

    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.

    Measured: Up to 18 Months

  7. Duration of Treatment (DoT)

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

    Measured: Up to 18 Months

  8. Percentage of participants with Adverse Events (AE)

    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.

    Measured: Up to 18 Months

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

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

    Measured: Up to 18 Months

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

    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.

    Measured: Up to 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start30 Nov 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587049
Sponsor's protocol ID
P23-469
Acronym
ESVECO
Status last verified
Aug 2026
First submitted
18 Oct 2022
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia, run by AbbVie at 8 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela Duarte (+57 1 638-5000, angela.duarte@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05587049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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