Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- AbbVie
- Enrollment
- 120
- Locations
- 19
- Primary Endpoint
- Percentage of Participants Achieving Overall Survival (OS)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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 Switzerland & Austria.
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 120 participants will be enrolled in the study in approximately 15 sites in Switzerland & Austria.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 24 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 24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Newly-diagnosed AML and eligible to receive venetoclax as per local 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
- •\- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Outcomes
Primary Outcomes
Percentage of Participants Achieving Overall Survival (OS)
Time Frame: Up to Month 24
OS is defined as the time from treatment initiation to death from any cause.
Secondary Outcomes
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important(Up to Month 24)
- Percentage of Participants Achieving Composite Complete Remission(Up to Month 24)
- Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC)(Up to Month 24)
- Time to Transfusion Independence(Up to Month 24)
- Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important(Up to Month 24)