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

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 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.

Official Title
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A Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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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: - 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 30 Months | 

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 30 Months | 
| Total Time of Treatment with Venetoclax Combination Therapy | The total time of treatment with venetoclax combination therapy. | Up to 30 Months | 
| Time to Transfusion Independence | Total duration of transfusion independence is defined as the period of at least 56 days with no Red Blood Cell (RBC) or platelet transfusion between the first dose of study drug and the last dose of study drug plus 30 days. | Up to 30 Months | 
| Post Baseline RBC and Platelet Transfusion Independence Rate | Post baseline RBC and platelet transfusion independence rate will be calculated as the proportion of participants who achieved RBC and platelet, respectively, transfusion independence post baseline. | Up to 30 Months | 
| 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 30 Months | 
| Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) | Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs (dosing with venetoclax and any modifications/interruptions/titrations, type and dosing of each HMA, frequency of response assessment, cycle length, dosing, concomitant medications, etc). | Up to 30 Months | 
| Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting | Healthcare resource utilization as the number of transfusions (red blood cell [RBC] or platelets) received during first-line treatment in an outpatient setting. | Up to 30 Months | 
| Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment | Healthcare resource utilization as the number of hospitalizations during first-line treatment. | Up to 30 Months | 
| Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment | Healthcare resource utilization as the number of intensive care unit (ICU) admissions during first-line treatment. | Up to 30 Months | 
| Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner | Healthcare resource utilization as the number of visits in a private healthcare practitioner. | Up to 30 Months | 
| Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other) | Healthcare resource utilization as the name of relevant medication due to infections (antibiotics or other). | Up to 30 Months | 
| Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other) | Healthcare resource utilization as the dosing scheme of relevant medication due to infections (antibiotics or other). | Up to 30 Months | 
| Healthcare Resource Utilization as the Number of Laboratory Tests | Healthcare resource utilization as the number of laboratory tests. | Up to 30 Months | 
| Healthcare Resource Utilization as the Type of Laboratory Tests | Healthcare resource utilization as the type of laboratory tests. | Up to 30 Months | 

 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