Clinical trial · Observational
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy in Switzerland and Austria Receiving Oral Venetoclax Tablets
Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Venetoclax Participants
- description
- Participants treated with Venetoclax in accordance with approved local label.
Primary outcomes (1)
- measure
- Percentage of Participants Achieving Overall Survival (OS)
- timeFrame
- Up to Month 24
- description
- OS is defined as the time from treatment initiation to death from any cause.
Secondary outcomes (5)
- measure
- Percentage of Participants Achieving Composite Complete Remission
- timeFrame
- Up to Month 24
- description
- Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available