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NCT Number: NCT07030400

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

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.

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Key information

Conditions

Small Lymphocytic Lymphoma (SLL) Chronic Disease Chronic Lymphocytic Leukemia (CLL) Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Dorothie Durosier Mertilus, PhD

SUB_INVESTIGATOR

Richie Reich, PhD

SUB_INVESTIGATOR

Sara Tinsley-Vance, PhD, APRN, AOCN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bruton's tyrosine kinase inhibitor

Drug

BTKi

B-Cell Lymphoma 2 Protein Inhibitor

Drug

BCL2i

Primary outcomes

  1. Health Related Quality of Life (HRQOL)

    Time frame: 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.

  2. HRQOL predictors

    Time frame: 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.

  3. Interactions with treatment

    Time frame: Up to 2 years

    Three models will assess interactions between treatment and age, comorbidity, and fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Lastorino

CONTACT

[email protected]

813-745-0092

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • AstraZeneca
  • National Comprehensive Cancer Network

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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