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 (SURVIVE)

AbbVie

Status

Enrolling

Conditions

Acute Myeloid Leukemia

Study type

Observational

Funder types

Industry

Identifiers

NCT05317494

P22-535

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 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Exclusion criteria