Highlights of the NCCN Oncology Research Program
This study will enroll 100 patients aged $18 years with a pathology-confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are within 7 days of starting treatment with either a Br uton's tyrosine kinase inhibitor (BTKi) with or without an anti-CD20 monoclonal antibody or a B-cell lymphoma 2 inhibitor (BCL2i) with obinutuzumab.A total of 50 patients will be enrolled on each arm.Questionnaires will be administered to measure quality of life, symptoms, symptom distress, and fatigue at 8 time points: within 7 days of beginning new treatment; on days 30, 60, 90, and 180; and at 1, 1.5, and 2 years after treatment initiation.Results from this pilot study can be used to build a model incorporating significant patient and disease factors for future patients to inform their involvement in shared decision-making.This future prediction model may help patients align treatment choice with their values, goals, and preferences.The positive impact of this research will be to shift the emphasis from progression-free survival and treatment response to quality of survival. Primary Objective/Aim:Compare trajectories of health-related quality of life (HRQoL), as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu), between patients receiving BTKi and BCL2i, starting within 7 days of treatment initiation and continuing across 8 time points over 2 yearsSecondary Objective/Aims: Evaluate predictors of HRQoL in patients with CLL, including age, comorbidity (Hematopoietic Comorbidity Index), fatigue (Brief Fatigue Inventory), symptoms (Memorial Symptom Assessment Scale-Short Form), frailty (Clinical Frailty Scale), and disease characteristics Test whether treatment moderates the relationship between age, comorbidity, and fatigue and HRQoL
Publication Details
- Journal
- Journal of the National Comprehensive Cancer Network
- Published
- 2025-08-01
- DOI
- https://doi.org/10.6004/jnccn.2025.0040
- Primary Topic
- Cancer Treatment and Pharmacology
- Type
- article
- Field-Weighted Citation Impact
- 0.00