Small Lymphocytic Lymphoma (SLL)NCT07030400
Predictors of Health-Related QOL in Adults With CLL or Small Lymphocytic Lymphoma
An observational study of Small Lymphocytic Lymphoma (SLL) and Chronic Lymphocytic Leukemia (CLL), run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Lymphocytic Lymphoma (SLL), Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- Bruton's tyrosine kinase inhibitor and B-Cell Lymphoma 2 Protein Inhibitor
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18 years of age and older with a diagnosis of CLL/SLL who are starting treatment with either a Bruton tyrosine kinase inhibitor +/-an anti-CD 20 monoclonal antibody or a B cell lymphoma 2 inhibitor (BCL2i) with Obinutuzumab.
Who may be able to join
- 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.
Who cannot join
- Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Sara Tinsley-Vance, PhD, APRN, AOCN
Dorothie Durosier Mertilus, PhD
About this study
Official title: Predictors of Health-Related Quality of Life in Adults With Chronic Lymphocytic Leukemia 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.
- Being tested
- Bruton's tyrosine kinase inhibitor, B-Cell Lymphoma 2 Protein Inhibitor
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruton's tyrosine kinase inhibitorDrug
BTKi
B-Cell Lymphoma 2 Protein InhibitorDrug
BCL2i
| Study group | Role | What they receive |
|---|---|---|
| Bruton's tyrosine kinase inhibitor treatment | Patients treated with a Bruton's tyrosine kinase inhibitor. Receives: Drug: Bruton's tyrosine kinase inhibitor | |
| B-Cell Lymphoma 2 Protein Inhibitor treatment | Patients treated with a B-Cell Lymphoma 2 Protein Inhibitor. Receives: Drug: B-Cell Lymphoma 2 Protein Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (HRQOL)
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.
Measured: Up to 2 years
HRQOL predictors
Investigators will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to the slope of HRQOL in separate models.
Measured: Up to 2 years
Interactions with treatment
Three models will assess interactions between treatment and age, comorbidity, and fatigue.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start17 Jul 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Lymphocytic Lymphoma (SLL)Studies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Sara Tinsley-Vance, PhD, APRN, AOCN, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030400
- Sponsor's protocol ID
- MCC-23558
- Status last verified
- Mar 2026
- First submitted
- 12 Jun 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Health-Related Quality of Life in Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT07030400
- Acronym / sponsor ID
- MCC-23558
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, AstraZeneca
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruton's tyrosine kinase inhibitor treatment | – | Drug: Bruton's tyrosine kinase inhibitorPatients treated with a Bruton's tyrosine kinase inhibitor. |
| B-Cell Lymphoma 2 Protein Inhibitor treatment | – | Drug: B-Cell Lymphoma 2 Protein InhibitorPatients treated with a B-Cell Lymphoma 2 Protein Inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years of age and older with a diagnosis of CLL/SLL who are starting treatment with either a Bruton tyrosine kinase inhibitor +/-an anti-CD 20 monoclonal antibody or a B cell lymphoma 2 inhibitor (BCL2i) with Obinutuzumab.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruton's tyrosine kinase inhibitorBTKi | Drug | Bruton's tyrosine kinase inhibitor treatment |
| B-Cell Lymphoma 2 Protein InhibitorBCL2i | Drug | B-Cell Lymphoma 2 Protein Inhibitor treatment |
Primary outcome
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.
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.
Interactions with treatment
Time frame: Up to 2 years
Three models will assess interactions between treatment and age, comorbidity, and fatigue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Small Lymphocytic Lymphoma (SLL)
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Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
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RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
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RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Tinsley-Vance, PhD, APRN, AOCN principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Lymphocytic Lymphoma (SLL) and Chronic Lymphocytic Leukemia (CLL), run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lastorino (813-745-0092, Daniel.Lastorino@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (HRQOL) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.