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.
Study Type
OBSERVATIONAL
Enrollment
100
Olympion General Clinic /ID# 268392
Pátrai, Achaia, Greece
ACTIVE_NOT_RECRUITINGGeneral Hospital of Athens Gennimatas /ID# 245968
Athens, Attica, Greece
ACTIVE_NOT_RECRUITINGGeneral Hospital of Athens Laiko /ID# 244338
Athens, Attica, Greece
ACTIVE_NOT_RECRUITINGUniversity General Hospital Attikon /ID# 248265
Athens, Attica, Greece
ACTIVE_NOT_RECRUITINGUniversity General Hospital of Heraklion PA.G.N.I /ID# 244337
Heraklion, Crete, Greece
COMPLETEDGeneral University Hospital of Alexandroupolis /ID# 244235
Alexandroupoli, Greece
ACTIVE_NOT_RECRUITINGGeneral Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
Athens, Greece
ACTIVE_NOT_RECRUITINGGeneral Anti-cancer Hospital Agios Savvas /ID# 244408
Athens, Greece
ACTIVE_NOT_RECRUITINGGeneral Hospital of Athens Laiko - Hematology Location /ID# 244234
Athens, Greece
ACTIVE_NOT_RECRUITINGUniversity General Hospital of Ioannina /ID# 244336
Ioannina, Greece
ACTIVE_NOT_RECRUITING...and 3 more locations
Percentage of Participants Achieving Overall Survival (OS)
OS is defined as the time from treatment initiation to death from any cause.
Time frame: Up to 30 Months
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).
Time frame: Up to 30 Months
Total Time of Treatment with Venetoclax Combination Therapy
The total time of treatment with venetoclax combination therapy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Up to 30 Months
Healthcare Resource Utilization as the Number of Laboratory Tests
Healthcare resource utilization as the number of laboratory tests.
Time frame: Up to 30 Months
Healthcare Resource Utilization as the Type of Laboratory Tests
Healthcare resource utilization as the type of laboratory tests.
Time frame: Up to 30 Months
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