NCT05555979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 14, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

September 23, 2022

Last Update Submit

June 26, 2025

Conditions

Keywords

Chronic Lymphocytic LeukemiaRituximabBruton's Tyrosine Kinase InhibitorVenetoclaxVenclextaVenclyxtoABT-199Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with a Change in Chronic Lymphocytic Leukemia (CLL) Symptoms

    Number of participants who report a change in CLL symptoms through qualitative interviews.

    Day 1

Study Arms (1)

Chronic Lymphocytic Leukemia (CLL) Participants

Participants treated with venetoclax+rituximab or bruton's tyrosine kinase inhibitors in accordance with approved local label.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Barts Health NHS Trust /ID# 252717

London, London, City of, E1 2ES, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Nottingham City Hospital /ID# 252716

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust /ID# 252715

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

University Hospitals Sussex NHS Foundation Trust /ID# 252672

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

University Hospitals of Leicester NHS Trust /ID# 252719

Leicester, LE1 5WW, United Kingdom

Location

The Royal Marsden NHS Foundation Trust /ID# 252655

London, SW3 6JJ, United Kingdom

Location

Portsmouth Hospitals University NHS Trust /ID# 252722

Portsmouth, PO6 3LY, United Kingdom

Location

Sunderland Royal Hospital /ID# 252495

Sunderland, SR4 7TN, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust /ID# 252721

Taunton, TA1 5DA, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellNeoplasms

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

December 14, 2022

Primary Completion

April 10, 2024

Study Completion

April 10, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations