Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

Objective This study was designed to compare treatment patterns, clinical trial participation, and clinical outcomes among patients with small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) or Mantle cell lymphoma (MCL) by site of care.Methods A nationwide electronic health record (EHR)-der...

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Main Authors: Debora S. Bruno, Manoj Khanal, Xiaohong Li, Maricer P. Escalon, Katherine Winfree, Lisa M. Hess
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Hematology
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Online Access:https://www.tandfonline.com/doi/10.1080/16078454.2025.2457809
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author Debora S. Bruno
Manoj Khanal
Xiaohong Li
Maricer P. Escalon
Katherine Winfree
Lisa M. Hess
author_facet Debora S. Bruno
Manoj Khanal
Xiaohong Li
Maricer P. Escalon
Katherine Winfree
Lisa M. Hess
author_sort Debora S. Bruno
collection DOAJ
description Objective This study was designed to compare treatment patterns, clinical trial participation, and clinical outcomes among patients with small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) or Mantle cell lymphoma (MCL) by site of care.Methods A nationwide electronic health record (EHR)-derived de-identified database was utilized for this study. Eligible patients were diagnosed with either CLL or MCL from 2013–2022 who received systemic therapy for their disease. Overall survival (OS) was analyzed using Kaplan Meier method, censoring patients without events at last observation in the database. Cox proportional hazards regression model was used to adjust for baseline covariates.Results A total of 6,372 patients with CLL and 3,411 with MCL met eligibility criteria for this analysis; 13.9% and 22.2%, respectively, were treated in academic settings. Academic settings were associated with higher patient volume and were more likely to treat MCL with CAR-T, enroll patients with CLL or MCL to clinical trials, and care for patients who were younger, White, and for CLL with higher rates of del(17p) mutations (all p < 0.01). Survival was significantly longer among patients treated in academic vs community settings (median OS not reached vs 80.5 months for CLL; 95.6 vs 68.7 months for MCL from start of first-line therapy).Discussion Patients who received care in academic settings differed from those treated in the community; care in academic settings was associated with significantly longer OS and higher trial participation. Further research is warranted to better understand the factors that may contribute to the observed outcomes.
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spelling doaj-art-11610ca5ce9647a3bbb09056195f155f2025-02-06T06:22:42ZengTaylor & Francis GroupHematology1607-84542025-12-0130110.1080/16078454.2025.2457809Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell LymphomaDebora S. Bruno0Manoj Khanal1Xiaohong Li2Maricer P. Escalon3Katherine Winfree4Lisa M. Hess5University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH, USALilly Oncology, Eli Lilly and Company, Indianapolis, IN, USALilly Oncology, Eli Lilly and Company, Indianapolis, IN, USALilly Oncology, Eli Lilly and Company, Indianapolis, IN, USALilly Oncology, Eli Lilly and Company, Indianapolis, IN, USALilly Oncology, Eli Lilly and Company, Indianapolis, IN, USAObjective This study was designed to compare treatment patterns, clinical trial participation, and clinical outcomes among patients with small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) or Mantle cell lymphoma (MCL) by site of care.Methods A nationwide electronic health record (EHR)-derived de-identified database was utilized for this study. Eligible patients were diagnosed with either CLL or MCL from 2013–2022 who received systemic therapy for their disease. Overall survival (OS) was analyzed using Kaplan Meier method, censoring patients without events at last observation in the database. Cox proportional hazards regression model was used to adjust for baseline covariates.Results A total of 6,372 patients with CLL and 3,411 with MCL met eligibility criteria for this analysis; 13.9% and 22.2%, respectively, were treated in academic settings. Academic settings were associated with higher patient volume and were more likely to treat MCL with CAR-T, enroll patients with CLL or MCL to clinical trials, and care for patients who were younger, White, and for CLL with higher rates of del(17p) mutations (all p < 0.01). Survival was significantly longer among patients treated in academic vs community settings (median OS not reached vs 80.5 months for CLL; 95.6 vs 68.7 months for MCL from start of first-line therapy).Discussion Patients who received care in academic settings differed from those treated in the community; care in academic settings was associated with significantly longer OS and higher trial participation. Further research is warranted to better understand the factors that may contribute to the observed outcomes.https://www.tandfonline.com/doi/10.1080/16078454.2025.2457809Real-world datasite of careclinical trial participationpatient outcomesCLLMCL
spellingShingle Debora S. Bruno
Manoj Khanal
Xiaohong Li
Maricer P. Escalon
Katherine Winfree
Lisa M. Hess
Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
Hematology
Real-world data
site of care
clinical trial participation
patient outcomes
CLL
MCL
title Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
title_full Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
title_fullStr Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
title_full_unstemmed Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
title_short Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
title_sort clinical trial participation clinical care and patient outcomes by practice setting a real world database analysis of patients with chronic lymphocytic leukemia or mantle cell lymphoma
topic Real-world data
site of care
clinical trial participation
patient outcomes
CLL
MCL
url https://www.tandfonline.com/doi/10.1080/16078454.2025.2457809
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