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

AbbVie

Status: Completed

Conditions: Acute Myeloid Leukemia (AML)

Study type: Observational

Funder types: Industry

Identifiers

NCT04813263

P20-408

Details and patient eligibility

About

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.

Enrollment: 424 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants who are administered venetoclax for treatment of AML.

Exclusion criteria

None

Trial design

424 participants in 1 patient group

Participants Treated With Venetoclax

Description:

Participants who are administrated venetoclax for treatment of AML under routine clinical practice.