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

Recruiting now

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT05587049

Run by

AbbVie

People needed

70

Starts

2023-11-30

Expected to finish

2026-11-01

Last updated by the study team

2025-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Clinica del Country /ID# 248430 — Bogota, Cundinamarca, Colombia (enrolling)
• Fundación Santa Fé De Bogotá /ID# 248563 — Bogotá, Cundinamarca, Colombia (enrolling)
• Sociedad de Oncologia y Hematologia del Cesar /ID# 248615 — Valledupar, Cesar Department, Colombia (enrolling)
• Hospital Pablo Tobón Uribe /ID# 248569 — Medellín, Antioquia, Colombia (enrolling)
• Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570 — Bogota DC, Cundinamarca, Colombia
• Hospital Alma Mater de Antioquia /ID# 248562 — Medellin, Bogota D.C., Colombia
• Fundación Valle Del Lili /ID# 248294 — Cali, Valle del Cauca Department, Colombia

Full record on ClinicalTrials.gov

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