Predictors of Health-Related QOL in Adults With CLL or Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bruton's tyrosine kinase inhibitor
DrugBTKi
B-Cell Lymphoma 2 Protein Inhibitor
DrugBCL2i
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Bruton's tyrosine kinase inhibitor treatment1 intervention
Group B: B-Cell Lymphoma 2 Protein Inhibitor treatment1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 2 years2
HRQOL predictors
Investigators will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to the slope of HRQOL in separate models.
Time frame
Up to 2 years3
Interactions with treatment
Three models will assess interactions between treatment and age, comorbidity, and fatigue.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
National Comprehensive Cancer Network
Collaborator
AstraZeneca
Collaborator
Source ClinicalTrials.gov