A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation (INNOVATE)

AbbVie

Status: Completed

Conditions: Acute Myeloid Leukemia (AML)

Study type: Observational

Funder types: Industry

Identifiers

NCT04253314

P20-147

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 standard induction therapy in Russian Federation.

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 diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label
• Ineligible for standard induction therapy with cytarabine and anthracycline
• Eastern Cooperative Oncology Group (ECOG) score >2
• White blood cell counts <25 x 109 per liter
• Started Venetoclax within 4 weeks of enrolling in study

Exclusion criteria

• Acute promyelocytic leukemia
• Contraindications to Venetoclax as listed on the approved local label in Russian Federation
• Neuroleukemia - active central nervous system (CNS) involvement
• Participation in a clinical trial with an investigational drug for AML within 30 days prior to Venetoclax treatment initiation

Trial design

51 participants in 1 patient group

Venetoclax Participants

Description:

Participants treated with Venetoclax in accordance with approved local label. Decision to treat with Venetoclax was made prior to offering participation in this study.