Predictors of Health-Related QOL in Adults With CLL or Small Lymphocytic Lymphoma

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07030400

Enrollment

100

Registered

2025-06-22

Start date

2025-07-17

Completion date

2028-06-01

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

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.

Interventions

DRUGBruton's tyrosine kinase inhibitor

BTKi

DRUGB-Cell Lymphoma 2 Protein Inhibitor

BCL2i

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Health Related Quality of Life (HRQOL)	Up to 2 years	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.
HRQOL predictors	Up to 2 years	Investigators will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to the slope of HRQOL in separate models.
Interactions with treatment	Up to 2 years	Three models will assess interactions between treatment and age, comorbidity, and fatigue.

Countries

United States

Contacts

CONTACTDaniel Lastorino

Daniel.Lastorino@moffitt.org813-745-0092

PRINCIPAL_INVESTIGATORSara Tinsley-Vance, PhD, APRN, AOCN

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026