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
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT05215639
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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 Month 24 OS is defined as the time from treatment initiation to death from any cause.
- Secondary Outcome Measures
Name Time Method 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.
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).
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.
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.
Trial Locations
- Locations (19)
Klinikum Klagenfurt am Wörthersee /ID# 247304
🇦🇹Klagenfurt am Wörthersee, Kaernten, Austria
Duplicate_Universitätsspital Basel /ID# 256509
🇨🇭Basel, Basel-Stadt, Switzerland
Inselspital, Universitaetsspital Bern /ID# 239241
🇨🇭Bern, Switzerland
Universitaetsklinikum St. Poelten /ID# 247283
🇦🇹Sankt Poelten, Niederoesterreich, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 247284
🇦🇹Linz, Oberoesterreich, Austria
Krankenhaus der Barmherzigen Brueder Graz /ID# 254121
🇦🇹Graz, Steiermark, Austria
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174
🇦🇹Leoben, Steiermark, Austria
Klinik Ottakring /ID# 247285
🇦🇹Vienna, Wien, Austria
Hanusch Krankenhaus /ID# 247282
🇦🇹Wien, Austria
Kantonsspital Aarau AG /ID# 251598
🇨🇭Aarau, Aargau, Switzerland
Kantonsspital Baden /ID# 241896
🇨🇭Baden, Aargau, Switzerland
Luzerner Kantonsspital /ID# 239242
🇨🇭Luzern 16, Luzern, Switzerland
Kantonsspital St. Gallen /ID# 239233
🇨🇭St. Gallen, Sankt Gallen, Switzerland
EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663
🇨🇭Bellinzona, Ticino, Switzerland
Spitalzentrum Oberwallis /ID# 241897
🇨🇭Brig, Valais, Switzerland
Hôpital du Chablais, Rennaz /ID# 241895
🇨🇭Rennaz, Vaud, Switzerland
KSW Kantonsspital Winterthur /ID# 239852
🇨🇭Winterthur, Zuerich, Switzerland
Hirslanden Zürich /ID# 239239
🇨🇭Zurich, Zuerich, Switzerland
Hôpital de Nyon /ID# 240720
🇨🇭Nyon, Switzerland