A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan

Study Identifier
P24-120
CT.gov Identifier
NCT06362044
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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 - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosed with relapsed/refractory (2 Line \[2L\]+) chronic lymphocytic leukemia (CLL) in Japan based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria at the time of informed consent (IC). * Treatment with Venetoclax±Rituximab for 24 months who are not treated with any other concurrent CLL treatment. * Expected to visit the hospital at + 3 months after treatment with Venetoclax±Rituximab for 24 months.
    Exclusion Criteria:
    * No data on information on the start and end dates or continuation of treatment with Venetoclax. * Participating in other clinical trials.

    Protocol Summary

    Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.

    Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.

    Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.

    There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

    Study Locations

    Location
    Status
    Location
    National Cancer Center Hospital East /ID# 265970
    Kashiwa-shi, Chiba, Japan, 277-8577
    Status
    Not applicable