A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece

Study Identifier
P22-535
CT.gov Identifier
NCT05317494
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
Sign up for trial alerts

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:
    * Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) 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 Greece.

    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 100 participants will be enrolled in the study in approximately 15 sites in Greece.

    Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 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 30 months.

    Study Locations

    Location
    Status
    Location
    Olympion General Clinic /ID# 268392
    Pátrai, Achaia, Greece, 25443
    Status
    Active, Not Recruiting
    Location
    General Hospital of Athens Gennimatas /ID# 245968
    Athens, Attica, Greece, 11527
    Status
    Active, Not Recruiting
    Location
    General Hospital of Athens Laiko /ID# 244338
    Athens, Attica, Greece, 11527
    Status
    Active, Not Recruiting
    Location
    University General Hospital Attikon /ID# 248265
    Athens, Attica, Greece, 12462
    Status
    Active, Not Recruiting
    Location
    University General Hospital of Heraklion PA.G.N.I /ID# 244337
    Heraklion, Crete, Greece, 71500
    Status
    Completed
    Location
    General University Hospital of Alexandroupolis /ID# 244235
    Alexandroupoli, Greece, 68100
    Status
    Active, Not Recruiting
    Showing {first} - {last} of {total} Results