A Study to Assess Change in Patient Experience in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets + Intravenous Rituximab or Bruton's Tyrosine Kinase Inhibitors Tablets in the United Kingdom

Study Identifier
P23-486
CT.gov Identifier
NCT05555979
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
Download document(s)

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:
    * Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) (as defined by 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines). * Has relapsed/refractory (R/R) disease having received only 1 prior line of treatment, which must have been a chemotherapy or chemoimmunotherapy treatment. * Has treatment experience with venetoclax+rituximab (Ven+R) or bruton's tyrosine kinase inhibitor (BTKi)s that meets the criteria for inclusion described in the protocol, for which recruitment targets have not yet been met.
    Exclusion Criteria:
    * Previously treated with a BTKi, a BCL-2 inhibitor or other investigational agents. * Has any other medical condition or disorder that, in the opinion of the site investigator or study director, could compromise participant's ability to give written informed consent and/or prevent or interfere with his or her ability to comply with study procedures and provide meaningful information about his or her CLL experience.

    Protocol Summary

    Chronic lymphocytic leukemia (CLL), a form of Non-Hodgkin's Lymphoma, is the most common type of leukemia in adults, affecting approximately 3,800 people in the UK each year. This study will evaluate the patient experience of CLL in adult participants who are prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors in the United Kingdom (UK).

    Venetoclax+rituximab is a drug approved to treat CLL. Study participants will receive venetoclax+rituximab as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors will be enrolled. Around 140 participants will be enrolled in the study in approximately 10 sites in the UK.

    Participants will receive venetoclax tablets to be taken by mouth and rituximab intravenous (IV) injection according to the approved local label.

    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
    Barts Health NHS Trust /ID# 252717
    London, London, City Of, United Kingdom, E1 2ES
    Status
    Not applicable
    Location
    Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720
    Norwich, Norfolk, United Kingdom, NR4 7UY
    Status
    Not applicable
    Location
    Nottingham City Hospital /ID# 252716
    Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    Status
    Not applicable
    Location
    Oxford University Hospitals NHS Foundation Trust /ID# 252715
    Oxford, Oxfordshire, United Kingdom, OX3 9DU
    Status
    Not applicable
    Location
    University Hospitals Sussex NHS Foundation Trust /ID# 252672
    Worthing, West Sussex, United Kingdom, BN11 2DH
    Status
    Not applicable
    Location
    University Hospitals of Leicester NHS Trust /ID# 252719
    Leicester, United Kingdom, LE1 5WW
    Status
    Not applicable
    Showing {first} - {last} of {total} Results