Clinical trial NCT05555979: 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
Official title: Qualitative, Cross-sectional Observational Study Exploring the Experience of Patients Prescribed Venetoclax+Rituximab or Bruton's Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukaemia in Clinical Practice in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Rituximab
Bruton's Tyrosine Kinase Inhibitor
Venetoclax
Venclexta
Venclyxto
ABT-199
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with second-line (2L) chronic lymphocytic leukemia (CLL) treated with venetoclax+rituximab or bruton's tyrosine kinase inhibitors per approved local label in the United Kingdom.

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with a Change in Chronic Lymphocytic Leukemia (CLL) Symptoms
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 252717
state: London, City Of
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720
state: Norfolk
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital /ID# 252716
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 252715
state: Oxfordshire
city: Worthing
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust /ID# 252672
state: West Sussex
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust /ID# 252719
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust /ID# 252655
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 252722
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital /ID# 252495
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust /ID# 252721
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: