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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2023-11-30
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-10-19
• Last updated: 2025-08-08

Locations

7 sites across 1 country: Colombia