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

NCT ID: NCT05215639

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-27

Study Completion Date

2025-11-24

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Venetoclax Participants

Participants treated with Venetoclax in accordance with approved local label.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Klinikum Klagenfurt am Wörthersee /ID# 247304

Klagenfurt, Carinthia, Austria

Site Status

Universitaetsklinikum St. Poelten /ID# 247283

Sankt Pölten, Lower Austria, Austria

Site Status

Krankenhaus der Barmherzigen Brueder Graz /ID# 254121

Graz, Styria, Austria

Site Status

Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174

Leoben, Styria, Austria

Site Status

Ordensklinikum Linz GmbH Elisabethinen /ID# 247284

Linz, Upper Austria, Austria

Site Status

Klinik Ottakring /ID# 247285

Vienna, Vienna, Austria

Site Status

Hanusch Krankenhaus /ID# 247282

Vienna, , Austria

Site Status

Kantonsspital Aarau AG /ID# 251598

Aarau, Canton of Aargau, Switzerland

Site Status

Kantonsspital Baden /ID# 241896

Baden, Canton of Aargau, Switzerland

Site Status

Duplicate_Universitätsspital Basel /ID# 256509

Basel, Canton of Basel-City, Switzerland

Site Status

Luzerner Kantonsspital /ID# 239242

Lucerne, Canton of Lucerne, Switzerland

Site Status

Kantonsspital St. Gallen /ID# 239233

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

Hôpital du Chablais, Rennaz /ID# 241895

Rennaz, Canton of Vaud, Switzerland

Site Status

KSW Kantonsspital Winterthur /ID# 239852

Winterthur, Canton of Zurich, Switzerland

Site Status

Hirslanden Klinik /ID# 239239

Zurich, Canton of Zurich, Switzerland

Site Status

EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663

Bellinzona, Canton Ticino, Switzerland

Site Status

Spitalzentrum Oberwallis /ID# 241897

Brig, Valais, Switzerland

Site Status

Inselspital, Universitaetsspital Bern /ID# 239241

Bern, , Switzerland

Site Status

Hôpital de Nyon /ID# 240720

Nyon, , Switzerland

Site Status

Countries

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Austria Switzerland

Related Links

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Other Identifiers

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P21-937

Identifier Type: -

Identifier Source: org_study_id

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