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NCT05555979 | Recruiting | Chronic Lymphocytic Leukemia


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

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

Chronic Lymphocytic Leukemia

Study Type : Observational
Estimated Enrollment : 140 participants
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 : December 14, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

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

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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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United Kingdom, London, City Of

Barts Health NHS Trust /ID# 252717

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

Recruiting

United Kingdom, Norfolk

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

Norwich, Norfolk, United Kingdom, NR4 7UY

Recruiting

United Kingdom, Nottinghamshire

Nottingham University Hospitals NHS Trust /ID# 252716

Nottingham, Nottinghamshire, United Kingdom, NG5 1PB

Recruiting

United Kingdom, Oxfordshire

Oxford University Hospitals NHS Foundation Trust /ID# 252715

Oxford, Oxfordshire, United Kingdom, Ksaa may

Recruiting

United Kingdom,

University Hospitals of Leicester NHS Trust /ID# 252719

Leicester, United Kingdom, LE1 5WW

Recruiting

United Kingdom,

The Royal Marsden NHS Foundation Trust /ID# 252655

London, United Kingdom, Sua taj

Recruiting

United Kingdom,

Portsmouth Hospitals University NHS Trust /ID# 252722

Portsmouth, United Kingdom, Duck on me

Recruiting

United Kingdom,

South Tyneside and Sunderland NHS Foundation Trust /ID# 252495

Sunderland, United Kingdom, SR4 7TP

Recruiting

United Kingdom,

Taunton and Somerset NHS Foundation Trust /ID# 252721

Taunton, United Kingdom, TA1 5DA

Recruiting

United Kingdom,

University Hospitals Sussex NHS Foundation Trust /ID# 252672

Worthing, United Kingdom, BN11 2DH

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