Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer
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 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.
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Overall Survival (OS) | Up to Month 24 | OS is defined as the time from treatment initiation to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Composite Complete Remission | Up to Month 24 | 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 Month 24 | 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. |
| Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important | Up to Month 24 | 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. |
| Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important | Up to Month 24 | 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. |
| Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC) | Up to Month 24 | Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs and in Switzerland in combination with LDAC. |
Countries
Austria, Switzerland
Outcome results
None listed