Recruiting

CLL vs. SLL

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07030400

Conditions

Small Lymphocytic Lymphoma (SLL)

Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bruton's tyrosine kinase inhibitor

B-Cell Lymphoma 2 Protein Inhibitor

Study Details

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.

Conditions

Small Lymphocytic Lymphoma (SLL)

Chronic Lymphocytic Leukemia (CLL)

Study ID

NCT07030400

Start date

Jul 17, 2025

Status verified date

Mar, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Bruton's tyrosine kinase inhibitor

BTKi

B-Cell Lymphoma 2 Protein Inhibitor

BCL2i

Primary outcome measure

  • Health Related Quality of Life (HRQOL) [ Time Frame: Up to 2 years ]
  • HRQOL predictors [ Time Frame: Up to 2 years ]
  • Interactions with treatment [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Sara Tinsley-Vance, PhD, APRN, AOCN

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-01.