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
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article

Highlights of the NCCN Oncology Research Program

Journal of the National Comprehensive Cancer Network
Cancer Treatment and Pharmacology
article

Highlights of the NCCN Oncology Research Program

article en

Abstract

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

Journal of the National Comprehensive Cancer NetworkVol. 23(8)
Openalex Percentile: Top 72%
Cancer Treatment and Pharmacology
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