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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Participants | Participants treated with Venetoclax in accordance with approved local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Overall Survival (OS) | OS is defined as the time from treatment initiation to death from any cause. | Up to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to Month 24 |
| Time to Transfusion Independence |
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Inclusion Criteria:
Exclusion Criteria:
- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
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Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Switzerland & Austria.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Klagenfurt am Wörthersee /ID# 247304 | Klagenfurt | Carinthia | 9020 | Austria | ||
| Universitaetsklinikum St. Poelten /ID# 247283 |
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| Label | URL |
|---|---|
| Related Info. | View source |
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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. |
| Up to Month 24 |
| 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. | Up to Month 24 |
| Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important | 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. | Up to Month 24 |
| Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC) | Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs and in Switzerland in combination with LDAC. | Up to Month 24 |
| Sankt Pölten |
| Lower Austria |
| 3100 |
| Austria |
| Klinik Ottakring /ID# 247285 | Vienna | State of Vienna | 1160 | Austria |
| Krankenhaus der Barmherzigen Brueder Graz /ID# 254121 | Graz | Styria | 8020 | Austria |
| Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174 | Leoben | Styria | 8700 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen /ID# 247284 | Linz | Upper Austria | 4010 | Austria |
| Hanusch Krankenhaus /ID# 247282 | Vienna | 1140 | Austria |
| Kantonsspital Aarau AG /ID# 251598 | Aarau | Canton of Aargau | 5001 | Switzerland |
| Kantonsspital Baden /ID# 241896 | Baden | Canton of Aargau | 5404 | Switzerland |
| Duplicate_Universitätsspital Basel /ID# 256509 | Basel | Canton of Basel-City | 4031 | Switzerland |
| Luzerner Kantonsspital /ID# 239242 | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Kantonsspital St. Gallen /ID# 239233 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Hôpital du Chablais, Rennaz /ID# 241895 | Rennaz | Canton of Vaud | 1847 | Switzerland |
| KSW Kantonsspital Winterthur /ID# 239852 | Winterthur | Canton of Zurich | 8400 | Switzerland |
| Hirslanden Klinik /ID# 239239 | Zurich | Canton of Zurich | 8032 | Switzerland |
| EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663 | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Spitalzentrum Oberwallis /ID# 241897 | Brig | Valais | 3900 | Switzerland |
| Inselspital, Universitaetsspital Bern /ID# 239241 | Bern | 3010 | Switzerland |
| Hôpital de Nyon /ID# 240720 | Nyon | 1260 | Switzerland |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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