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

NCT ID: NCT07030400

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-05

Study Completion Date

2028-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bruton's tyrosine kinase inhibitor treatment

Patients treated with a Bruton's tyrosine kinase inhibitor.

Bruton's tyrosine kinase inhibitor

Intervention Type DRUG

BTKi

B-Cell Lymphoma 2 Protein Inhibitor treatment

Patients treated with a B-Cell Lymphoma 2 Protein Inhibitor.

B-Cell Lymphoma 2 Protein Inhibitor

Intervention Type DRUG

BCL2i

Interventions

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Bruton's tyrosine kinase inhibitor

BTKi

Intervention Type DRUG

B-Cell Lymphoma 2 Protein Inhibitor

BCL2i

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Tinsley-Vance, PhD, APRN, AOCN

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Lastorino

Role: CONTACT

813-745-0092

Other Identifiers

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MCC-23558

Identifier Type: -

Identifier Source: org_study_id

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