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

Recruiting

• Conditions: Small Lymphocytic Lymphoma (SLL); Chronic Lymphocytic Leukemia (CLL)
• Interventions: Drug: Bruton's tyrosine kinase inhibitor; Drug: B-Cell Lymphoma 2 Protein Inhibitor

• Registration Number: NCT07030400
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-05
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bruton's tyrosine kinase inhibitor treatment	Bruton's tyrosine kinase inhibitor	Patients treated with a Bruton's tyrosine kinase inhibitor.
B-Cell Lymphoma 2 Protein Inhibitor treatment	B-Cell Lymphoma 2 Protein Inhibitor	Patients treated with a B-Cell Lymphoma 2 Protein Inhibitor.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States