NCT04813263

Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 424 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan. Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets. There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.

Conditions

• Acute Myeloid Leukemia (AML)

Timeline

• Start date: 2021-05-28
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2021-03-24
• Last updated: 2025-04-27

Locations

281 sites across 1 country: Japan