A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy in Switzerland and Austria Receiving Oral Venetoclax Tablets

Study Overview
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Brief Summary
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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.

Official Title
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Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venetoclax Participants<br>Participants treated with Venetoclax in accordance with approved local label. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Overall Survival (OS) | OS is defined as the time from treatment initiation to death from any cause. | Up to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Composite Complete Remission | Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi). | Up to Month 24 | 
| Time to Transfusion Independence | Time to transfusion independence is defined as the time between the date of first venetoclax intake and the absence of any Red Blood Cell (RBC) or platelet transfusion during any consecutive 8 and/or 16 weeks during the treatment period and percentage of participants achieving transfusion independence. | Up to Month 24 | 
| Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important | The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments. | Up to Month 24 | 
| Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important | The EORTC QLQ-C30 is developed to assess the quality of life of cancer patients and is based on multi-item and single-item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single-item measures. | Up to Month 24 | 
| Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC) | Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs and in Switzerland in combination with LDAC. | Up to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer