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 Canada (LIVEN)

AbbVie

Status: Active, not recruiting

Conditions: Acute Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT05424562

P23-363

Details and patient eligibility

About

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 induction chemotherapy in Canada.

Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). 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 induction chemotherapy will be enrolled. Around 200 participants will be enrolled in the study in approximately 15-20 sites in Canada.

Participants will receive venetoclax tablets to be taken by mouth daily 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 and participants will be followed for 36 months.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Acute Myeloid Leukemia (AML).
• Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice.
• Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.

Exclusion criteria

- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Trial design

210 participants in 1 patient group

Venetoclax Participants

Description:

Participants treated with Venetoclax in accordance with approved local label.