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

NCT05215639 | Completed

• 1 other identifier: P21-937
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 19

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Venetoclax; Venclexta; Venclyxto; ABT-199; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Participants Achieving Composite Complete Remission

  Up to Month 24

• Time to Transfusion Independence

  Up to Month 24

• Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important

  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

  Up to Month 24

• Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC)

  Up to Month 24

Study Arms (1)

Venetoclax Participants

Participants treated with Venetoclax in accordance with approved local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Switzerland \& Austria.

You may qualify if:

• 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.

You may not qualify if:

• \- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (19)

Klinikum Klagenfurt am Wörthersee /ID# 247304

Klagenfurt, Carinthia, 9020, Austria

Location

Universitaetsklinikum St. Poelten /ID# 247283

Sankt Pölten, Lower Austria, 3100, Austria

Location

Krankenhaus der Barmherzigen Brueder Graz /ID# 254121

Graz, Styria, 8020, Austria

Location

Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174

Leoben, Styria, 8700, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen /ID# 247284

Linz, Upper Austria, 4010, Austria

Location

Klinik Ottakring /ID# 247285

Vienna, Vienna, 1160, Austria

Location

Hanusch Krankenhaus /ID# 247282

Vienna, 1140, Austria

Location

Kantonsspital Aarau AG /ID# 251598

Aarau, Canton of Aargau, 5001, Switzerland

Location

Kantonsspital Baden /ID# 241896

Baden, Canton of Aargau, 5404, Switzerland

Location

Duplicate_Universitätsspital Basel /ID# 256509

Basel, Canton of Basel-City, 4031, Switzerland

Location

Luzerner Kantonsspital /ID# 239242

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Kantonsspital St. Gallen /ID# 239233

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Hôpital du Chablais, Rennaz /ID# 241895

Rennaz, Canton of Vaud, 1847, Switzerland

Location

KSW Kantonsspital Winterthur /ID# 239852

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Hirslanden Klinik /ID# 239239

Zurich, Canton of Zurich, 8032, Switzerland

Location

EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Spitalzentrum Oberwallis /ID# 241897

Brig, Valais, 3900, Switzerland

Location

Inselspital, Universitaetsspital Bern /ID# 239241

Bern, 3010, Switzerland

Location

Hôpital de Nyon /ID# 240720

Nyon, 1260, Switzerland

Location

Related Links

• Related Info.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 31, 2022
• Study Start: December 27, 2021
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

AU (7); CH (12)