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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05215639
Other study ID # P21-937
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 27, 2021
Est. completion date November 14, 2023

Study information

Verified date December 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date November 14, 2023
Est. primary completion date November 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Austria Krankenhaus der Barmherzigen Brueder Graz /ID# 254121 Graz Steiermark
Austria Klinikum Klagenfurt am Woerthersee /ID# 247304 Klagenfurt Am Woerthersee Kaernten
Austria Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174 Leoben Steiermark
Austria Ordensklinikum Linz GmbH Elisabethinen /ID# 247284 Linz Oberoesterreich
Austria Universitaetsklinikum St. Poelten /ID# 247283 Sankt Poelten Niederoesterreich
Austria Klinik Ottakring /ID# 247285 Vienna Wien
Austria Hanusch Krankenhaus /ID# 247282 Wien
Switzerland Kantonsspital Aarau AG /ID# 251598 Aarau Aargau
Switzerland Kantonsspital Baden /ID# 241896 Baden Aargau
Switzerland Universitätsspital Basel /ID# 256509 Basel Basel-Stadt
Switzerland EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663 Bellinzona Ticino
Switzerland Inselspital, Universitätsspital Bern /ID# 239241 Bern
Switzerland Spitalzentrum Oberwallis /ID# 241897 Brig
Switzerland Luzerner Kantonsspital /ID# 239242 Luzern 16 Luzern
Switzerland Hôpital de Nyon /ID# 240720 Nyon
Switzerland Hôpital du Chablais, Rennaz /ID# 241895 Rennaz
Switzerland Kantonsspital St. Gallen /ID# 239233 St. Gallen Sankt Gallen
Switzerland KSW Kantonsspital Winterthur /ID# 239852 Winterthur Zuerich
Switzerland Hirslanden Zürich /ID# 239239 Zurich

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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. Up to Month 24
Secondary 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
Secondary 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
Secondary 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
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