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
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT05555979
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with a Change in Chronic Lymphocytic Leukemia (CLL) Symptoms Day 1 Number of participants who report a change in CLL symptoms through qualitative interviews.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720
🇬🇧Norwich, Norfolk, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 252715
🇬🇧Oxford, Oxfordshire, United Kingdom
Barts Health NHS Trust /ID# 252717
🇬🇧London, London, City Of, United Kingdom
Nottingham City Hospital /ID# 252716
🇬🇧Nottingham, Nottinghamshire, United Kingdom
University Hospitals Sussex NHS Foundation Trust /ID# 252672
🇬🇧Worthing, West Sussex, United Kingdom
University Hospitals of Leicester NHS Trust /ID# 252719
🇬🇧Leicester, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 252655
🇬🇧London, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 252722
🇬🇧Portsmouth, United Kingdom
Sunderland Royal Hospital /ID# 252495
🇬🇧Sunderland, United Kingdom
Taunton and Somerset NHS Foundation Trust /ID# 252721
🇬🇧Taunton, United Kingdom