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 Canada

Study Identifier
P23-363
CT.gov Identifier
NCT05424562
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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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:
    * Diagnosis of Acute Myeloid Leukemia (AML). * Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice. * Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.
    Exclusion Criteria:
    \- Participation 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 induction chemotherapy in Canada.

    Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). 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 induction chemotherapy will be enrolled. Around 200 participants will be enrolled in the study in approximately 15-20 sites in Canada.

    Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 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 36 months.

    Study Locations

    Location
    Status
    Location
    Tom Baker Cancer Centre /ID# 248113
    Calgary, Alberta, Canada, T2N 4N2
    Status
    Not applicable
    Location
    University of Alberta Hospital /ID# 251531
    Edmonton, Alberta, Canada, T6G 2B7
    Status
    Not applicable
    Location
    BC Cancer - Surrey /ID# 257515
    Surrey, British Columbia, Canada, V3V 1Z2
    Status
    Not applicable
    Location
    Vancouver General Hospital /ID# 245438
    Vancouver, British Columbia, Canada, V5Z 1M9
    Status
    Not applicable
    Location
    BC Cancer - Victoria /ID# 257339
    Victoria, British Columbia, Canada, V8R 6V5
    Status
    Not applicable
    Location
    CancerCare Manitoba /ID# 246414
    Winnipeg, Manitoba, Canada, R3E 0V9
    Status
    Not applicable
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