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
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT05317494
- Lead Sponsor
- AbbVie
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Overall Survival (OS) Up to 30 Months OS is defined as the time from treatment initiation to death from any cause.
- Secondary Outcome Measures
Name Time Method Total Time of Treatment with Venetoclax Combination Therapy Up to 30 Months The total time of treatment with venetoclax combination therapy.
Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important Up to 30 Months 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.
Percentage of Participants Achieving Composite Complete Remission Up to 30 Months Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).
Time to Transfusion Independence Up to 30 Months 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.
Post Baseline RBC and Platelet Transfusion Independence Rate Up to 30 Months 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.
Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment Up to 30 Months Healthcare resource utilization as the number of hospitalizations 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 intensive care unit (ICU) admissions during first-line treatment.
Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner Up to 30 Months Healthcare resource utilization as the number of visits in a private healthcare practitioner.
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) Up to 30 Months 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).
Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other) Up to 30 Months Healthcare resource utilization as the name of relevant medication due to infections (antibiotics or other).
Healthcare Resource Utilization as the Type of Laboratory Tests Up to 30 Months Healthcare resource utilization as the type of laboratory tests.
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 transfusions (red blood cell \[RBC\] or platelets) received during first-line treatment in an outpatient setting.
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 dosing scheme of relevant medication due to infections (antibiotics or other).
Healthcare Resource Utilization as the Number of Laboratory Tests Up to 30 Months Healthcare resource utilization as the number of laboratory tests.
Trial Locations
- Locations (13)
University General Hospital Attikon /ID# 248265
🇬🇷Athens, Attiki, Greece
Olympion General Clinic /ID# 268392
🇬🇷Patras, Achaia, Greece
General Hospital of Athens Gennimatas /ID# 245968
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Laiko /ID# 244338
🇬🇷Athens, Attiki, Greece
General University Hospital of Alexandroupolis /ID# 244235
🇬🇷Alexandroupolis, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 244337
🇬🇷Heraklion, Kriti, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
🇬🇷Athens, Greece
General Anti-cancer Hospital Agios Savvas /ID# 244408
🇬🇷Athens, Greece
General Hospital of Athens Laiko - Hematology Location /ID# 244234
🇬🇷Athens, Greece
University General Hospital of Ioannina /ID# 244336
🇬🇷Ioannina, Greece
University General Hospital of Patras /ID# 244335
🇬🇷RION Patras Achaia, Greece
Papageorgiou General Hospital /ID# 248266
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 244237
🇬🇷Thessaloniki, Greece