Predictors of Health-Related QOL in Adults With CLL or Small Lymphocytic Lymphoma
1 other identifier
observational
100
1 country
1
Brief Summary
The study aims to improve our understanding of how quality of life, fatigue, and symptoms change over 2 years when participants are treated for chronic lymphocytic leukemia or small lymphocytic lymphoma. We will compare two types of treatment to help future patients with chronic lymphocytic leukemia or small lymphocytic lymphoma know what to anticipate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedStudy Start
First participant enrolled
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 1, 2026
March 1, 2026
2.9 years
June 12, 2025
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Health Related Quality of Life (HRQOL)
Compare the differences in HRQOL scores measured by the Functional Assessment of Cancer Therapy Leukemia version for patients receiving BTKi, and BCL2i within 7 days of beginning treatment and at days 30,60, 90, 180, 1 year, 1.5 years, and 2 years following initiation of treatment.
Up to 2 years
HRQOL predictors
Investigators will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to the slope of HRQOL in separate models.
Up to 2 years
Interactions with treatment
Three models will assess interactions between treatment and age, comorbidity, and fatigue.
Up to 2 years
Study Arms (2)
Bruton's tyrosine kinase inhibitor treatment
Patients treated with a Bruton's tyrosine kinase inhibitor.
B-Cell Lymphoma 2 Protein Inhibitor treatment
Patients treated with a B-Cell Lymphoma 2 Protein Inhibitor.
Interventions
Eligibility Criteria
Adults 18 years of age and older with a diagnosis of CLL/SLL who are starting treatment with either a Bruton tyrosine kinase inhibitor +/-an anti-CD 20 monoclonal antibody or a B cell lymphoma 2 inhibitor (BCL2i) with Obinutuzumab.
You may qualify if:
- All patients with pathology-confirmed diagnoses of CLL who are within seven days of starting treatment with a BTKi +/- an anti-CD 20 monoclonal antibody or BCL2i with Obinutuzumab treatment will be included.
- Subjects must be able to read and speak English or Spanish at the 8th grade level.
You may not qualify if:
- Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Comprehensive Cancer Networkcollaborator
- AstraZenecacollaborator
- H. Lee Moffitt Cancer Center and Research Institutelead
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Tinsley-Vance, PhD, APRN, AOCN
Moffitt Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2025
First Posted
June 22, 2025
Study Start
July 17, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03