Quality of life and symptom changes over two years in adults with CLL or SLL starting targeted therapy
Predictors of Health-Related Quality of Life in Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This study will see how quality of life, fatigue, and symptoms change over two years for adults with CLL or SLL who start treatment with a BTK inhibitor versus a BCL2 inhibitor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | Obinutuzumab |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT07030400 on ClinicalTrials.gov |
What this trial studies
This observational cohort enrolls adults with pathology-confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within seven days of beginning treatment with either a Bruton's tyrosine kinase inhibitor (BTKi) — with or without an anti-CD20 antibody — or a BCL2 inhibitor given with obinutuzumab. Participants complete standardized patient-reported outcome measures of quality of life, fatigue, and symptoms at scheduled intervals and are followed for two years. Analyses will compare the trajectories of these patient-reported outcomes between the two treatment groups while adjusting for clinical and demographic factors. The study is conducted at H. Lee Moffitt Cancer Center in collaboration with the NCCN and industry partners.
Who should consider this trial
Good fit: Adults with pathology-confirmed CLL or SLL who are within seven days of starting a BTKi (with or without an anti-CD20 antibody) or a BCL2 inhibitor given with obinutuzumab, and who can read English or Spanish at an eighth-grade level, are ideal candidates.
Not a fit: Patients who are not starting the specified therapies, have dementia, traumatic brain injury, central nervous system involvement of leukemia, or cannot attend follow-up at the study site are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the results could help future patients and clinicians anticipate quality-of-life changes with these treatments and make more informed therapy choices.
How similar studies have performed: Previous trials and real-world studies have reported quality-of-life impacts and differing side-effect profiles for BTK inhibitors and BCL2 inhibitors, but direct two-year, head-to-head patient-reported outcome comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sara Tinsley-Vance, PhD, APRN, AOCN — Moffitt Cancer Center
- Study coordinator: Daniel Lastorino
- Email: Daniel.Lastorino@moffitt.org
- Phone: 813-745-0092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.