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

Study Identifier
P21-937
CT.gov Identifier
NCT05215639
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Klinikum Klagenfurt am Wörthersee /ID# 247304
    Klagenfurt, Carinthia, Austria, 9020
    Status
    Not applicable
    Location
    Universitaetsklinikum St. Poelten /ID# 247283
    Sankt Pölten, Lower Austria, Austria, 3100
    Status
    Not applicable
    Location
    Klinik Ottakring /ID# 247285
    Vienna, State of Vienna, Austria, 1160
    Status
    Not applicable
    Location
    Krankenhaus der Barmherzigen Brueder Graz /ID# 254121
    Graz, Styria, Austria, 8020
    Status
    Not applicable
    Location
    Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174
    Leoben, Styria, Austria, 8700
    Status
    Not applicable
    Location
    Ordensklinikum Linz GmbH Elisabethinen /ID# 247284
    Linz, Upper Austria, Austria, 4010
    Status
    Not applicable
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