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

NCT05587049 | Recruiting

• 1 other identifier: P23-469
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Venetoclax; Venclexta; Venclyxto; Azacitidine; ABT-199; Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

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

  Up to 18 months

Secondary Outcomes (10)

• Percentage of Participants Achieving Complete Remission (CR)

  Up to 18 Months

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

  Up to 18 Months

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

  Up to 18 Months

• Percentage of Participants Achieving Transfusion Independence

  Up to 18 Months

• Event-Free Survival (EFS)

  Up to 18 Months

Study Arms (1)

Venetoclax + Azacitidine Participants

Participants treated with venetoclax in combination with azacitidine in accordance with approved local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

Hospital Pablo Tobón Uribe /ID# 248569

Medellín, Antioquia, 050034, Colombia

RECRUITING

Hospital Alma Mater de Antioquia /ID# 248562

Medellin, Bogota D.C., 50010, Colombia

ACTIVE NOT RECRUITING

Sociedad de Oncologia y Hematologia del Cesar /ID# 248615

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

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

Bogota DC, Cundinamarca, 111221, Colombia

ACTIVE NOT RECRUITING

Clinica del Country /ID# 248430

Bogota, Cundinamarca, 110231, Colombia

RECRUITING

Fundación Santa Fé De Bogotá /ID# 248563

Bogotá, Cundinamarca, 110111, Colombia

RECRUITING

Fundación Valle Del Lili /ID# 248294

Cali, Valle del Cauca Department, 760016, Colombia

ACTIVE NOT RECRUITING

Related Links

• Related info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Angela Duarte

CONTACT

+57 1 638-5000; angela.duarte@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 19, 2022
• Study Start: November 30, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CO (7)