Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia

Study Identifier
P20-486
CT.gov Identifier
NCT04655261
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL). * Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.
    Exclusion Criteria:
    * Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation. * Creatinine Clearance \< 30 milliLitres/minute. * Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma. * Participating in a clinical trial with an investigative drug for CLL.

    Protocol Summary

    Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.

    Venetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.

    Participants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.

    There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Moscow State budget healthcare /ID# 226058
    Moscow, Moscow, Russian Federation, 125284
    Status
    Not applicable
    Location
    Regional Children's Clinical Hospital of Volgograd /ID# 238328
    Volgograd, Volgograd Oblast, Russian Federation, 400138
    Status
    Not applicable
    Location
    Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127
    Saint Petersburg, Russian Federation, 191024
    Status
    Not applicable
    Location
    Tula Regional Clinical Hospital /ID# 231128
    Tula, Russian Federation, 300053
    Status
    Not applicable