Clinical trial Recruiting at 1 site Observational Ages 18 and up

Quality of life and symptom changes over two years in adults with CLL or SLL starting targeted therapy

Official title: Predictors of Health-Related Quality of Life in Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Run by H. Lee Moffitt Cancer Center and Research Institute · NCT07030400 · Data updated 2026-11-12

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.

More Chronic Lymphocytic Leukemia (CLL) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorH. Lee Moffitt Cancer Center and Research Institute
Academic / other
Drugs / interventionsObinutuzumab
Locations1 site (Tampa, Florida)
StatusRecruiting
StartedJuly 17, 2025
Main results expectedJune 2028
Study endsJune 2028
Registry record updatedApril 1, 2026
Trial IDNCT07030400 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.