Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Venetoclax
Brief summary
This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health. * Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
Exclusion criteria
\- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Time from treatment to death from any cause, up to approximately 30 months | Overall survival is defined as the time from the date of first treatment to the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving composite complete remission (CR or CRi) | Approximately 30 months | The percentage of participants achieving CR or CRi will be calculated based on the modified International Working Group (IWG) criteria for AML. |
| Time to transfusion independence | Up to 30 months | Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period. |
| Percentage of participants achieving transfusion independence | Up to 30 months | Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period. |
| Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics | Up to approximately 30 months | The percentage of participants treated with venetoclax in combination with Hypomethylating Agents (HMAs) and Low Dose Cytarabine (LDAC) will demonstrate treatment patterns of prescribing physicians. |
| Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30) | Week 0 to approximately 30 months | EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). |
| Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) | Week 0 to approximately 30 months | The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state. |
Countries
Israel
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed