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RECRUITING
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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2023-11-30

Completion Date

2026-11

Last Updated

2025-08-08

Healthy Volunteers

No

Locations (7)

Hospital Pablo Tobón Uribe /ID# 248569

Medellín, Antioquia, Colombia

Hospital Alma Mater de Antioquia /ID# 248562

Medellin, Bogota D.C., Colombia

Sociedad de Oncologia y Hematologia del Cesar /ID# 248615

Valledupar, Cesar Department, Colombia

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

Bogota DC, Cundinamarca, Colombia

Clinica del Country /ID# 248430

Bogota, Cundinamarca, Colombia

Fundación Santa Fé De Bogotá /ID# 248563

Bogotá, Cundinamarca, Colombia

Fundación Valle Del Lili /ID# 248294

Cali, Valle del Cauca Department, Colombia