A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

Study Identifier
P20-147
CT.gov Identifier
NCT04253314
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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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:
    * Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label * Ineligible for standard induction therapy with cytarabine and anthracycline * Eastern Cooperative Oncology Group (ECOG) score \>2 * White blood cell counts \<25 x 109 per liter * Started Venetoclax within 4 weeks of enrolling in study
    Exclusion Criteria:
    * Acute promyelocytic leukemia * Contraindications to Venetoclax as listed on the approved local label in Russian Federation * Neuroleukemia - active central nervous system (CNS) involvement * Participation in a clinical trial with an investigational drug for AML 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 standard induction therapy in Russian Federation.

    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 diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation.

    Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months.

    There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

    Study Locations

    Location
    Status
    Location
    Moscow State budget healthcare /ID# 218569
    Moscow, Moscow, Russian Federation, 125284
    Status
    Not applicable
    Location
    Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059
    Saratov, Saratov Oblast, Russian Federation, 410012
    Status
    Not applicable
    Location
    Hematology department State budgetary health care institution Volgograd region /ID# 229813
    Volgograd, Volgograd Oblast, Russian Federation, 400138
    Status
    Not applicable
    Location
    Regional Clinical Hospital of Irkutsk /ID# 218570
    Irkutsk, Russian Federation, 664049
    Status
    Not applicable
    Location
    Clinical Medico-Sanitary Unit #1 /ID# 222502
    Perm, Russian Federation, 614077
    Status
    Not applicable
    Location
    Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812
    Saint Petersburg, Russian Federation, 191024
    Status
    Not applicable
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