RecruitingNCT05587049

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

Sponsor

AbbVie

Enrollment

70 participants

Start Date

Nov 30, 2023

Study Type

OBSERVATIONAL

Conditions

Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is observing how well venetoclax plus azacitidine — a standard treatment combination for older or frailer adults with newly diagnosed AML (acute myeloid leukemia) — works in real-world conditions in Colombia. It is not randomized; it simply tracks what happens to patients receiving this approved treatment. **You may be eligible if...** - You have been newly diagnosed with AML and have not yet received any AML treatment - You are 75 or older, OR you are 18–74 with health conditions (like heart, lung, liver, or kidney problems) that make intensive chemotherapy too risky - You are starting venetoclax plus azacitidine treatment and have not yet completed your first full cycle **You may NOT be eligible if...** - You are currently participating in another interventional clinical trial - You have already received prior treatment for AML - You are eligible for and able to receive intensive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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