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

AbbVie120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Acute Myeloid Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

Klinikum Klagenfurt am Wörthersee /ID# 247304

Klagenfurt, Carinthia, Austria

Universitaetsklinikum St. Poelten /ID# 247283

Sankt Pölten, Lower Austria, Austria

Klinik Ottakring /ID# 247285

Vienna, State of Vienna, Austria

Krankenhaus der Barmherzigen Brueder Graz /ID# 254121

Graz, Styria, Austria

Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174

Leoben, Styria, Austria

Ordensklinikum Linz GmbH Elisabethinen /ID# 247284

Linz, Upper Austria, Austria

Hanusch Krankenhaus /ID# 247282

Vienna, Austria

Kantonsspital Aarau AG /ID# 251598

Aarau, Canton of Aargau, Switzerland

Kantonsspital Baden /ID# 241896

Baden, Canton of Aargau, Switzerland

Duplicate_Universitätsspital Basel /ID# 256509

Basel, Canton of Basel-City, Switzerland

...and 9 more locations

Outcomes

Primary Outcomes

Percentage of Participants Achieving Overall Survival (OS)

OS is defined as the time from treatment initiation to death from any cause.

Time frame: Up to Month 24

Secondary Outcomes

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).

Time frame: Up to Month 24

Time to Transfusion Independence

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Month 24