NCT05317494

A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece

A Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (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 works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled. Around 100 participants will be enrolled in the study in approximately 15 sites in Greece. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months.

Conditions

• Acute Myeloid Leukemia

Timeline

• Start date: 2022-05-26
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-04-07
• Last updated: 2025-07-16

Locations

13 sites across 1 country: Greece