ELECTRIC: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05555979

Collaborator

(none)

140

Enrollment

Locations

9.5

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Chronic Lymphocytic Leukemia (CLL) Participants Participants treated with venetoclax+rituximab or bruton's tyrosine kinase inhibitors in accordance with approved local label.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barts Health NHS Trust /ID# 252717	London	London, City Of	United Kingdom	E1 2ES
2	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720	Norwich	Norfolk	United Kingdom	NR4 7UY
3	Nottingham University Hospitals NHS Trust /ID# 252716	Nottingham	Nottinghamshire	United Kingdom	NG5 1PB
4	Oxford University Hospitals NHS Foundation Trust /ID# 252715	Oxford	Oxfordshire	United Kingdom	OX3 9DU
5	University Hospitals of Leicester NHS Trust /ID# 252719	Leicester		United Kingdom	LE1 5WW
6	The Royal Marsden NHS Foundation Trust /ID# 252655	London		United Kingdom	SW3 6JJ
7	Portsmouth Hospitals University NHS Trust /ID# 252722	Portsmouth		United Kingdom	PO6 3LY
8	South Tyneside and Sunderland NHS Foundation Trust /ID# 252495	Sunderland		United Kingdom	SR4 7TP
9	Taunton and Somerset NHS Foundation Trust /ID# 252721	Taunton		United Kingdom	TA1 5DA
10	University Hospitals Sussex NHS Foundation Trust /ID# 252672	Worthing		United Kingdom	BN11 2DH