在侵袭性b细胞非霍奇金淋巴瘤研究中排除艾滋病毒感染者：2014年至2024年临床试验的横断面分析

IF 1.8 4区医学 Q3 ONCOLOGY

Cancer Investigation Pub Date : 2025-02-01 Epub Date: 2025-02-08 DOI:10.1080/07357907.2025.2462568

Daniel J Olivieri, Ajay K Gopal, Thomas S Uldrick, Manoj P Menon

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引用次数: 0

摘要

背景：人类免疫缺陷病毒与各种侵袭性非霍奇金b细胞淋巴瘤（NHL）的发展有关。尽管如此，艾滋病毒感染者（PLWH）经常被排除在临床试验之外。在这里，我们分析了自2017年以来多边倡导努力导致的PLWH临床试验排除的变化。方法：我们使用公开的NIH临床试验数据库（https://www.clinicaltrials.gov/），确定了所有以“淋巴瘤”为关键词，开始日期在2014年1月1日至2025年1月4日之间的美国临床试验。所有具有侵袭性b细胞NHL亚型的研究均被纳入。采用回归模型对描述性因素进行分析。结果：收集了1973项美国临床试验，其中945项符合进一步分析的标准。2018年前和2018年后分别有59%和48%的患者排除了PLWH。结论：可能部分由于ASCO、NCI和NCCN的倡导，在美国NHL临床试验中，PLWH的排除率显著降低。未来的研究应分析免疫治疗在PLWH中的安全性和有效性，以促进包容并减少医生和研究人员的耻辱感。

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Exclusion of People Living with HIV in Aggressive B-Cell Non-Hodgkin Lymphoma Studies: A Cross-Sectional Analysis of Clinical Trials from 2014 to 2024.

Background: Human immunodeficiency virus is associated with the development of various aggressive non-Hodgkin B-cell lymphomas (NHL). Despite this, people living with HIV (PLWH) are often excluded from clinical trials. Here we analyze the change in clinical trial exclusion among PLWH resulting from multilateral advocacy efforts since 2017.

Methods: We identified all US-based clinical trials with the keyword "lymphoma" with start dates between January 01, 2014 and January 04, 2025 using the publicly available NIH Clinical Trial Database (https://www.clinicaltrials.gov/). All studies with aggressive B-cell NHL subtypes were included. Regression models were performed to analyze descriptive factors.

Results: 1,973 US-based clinical trials were captured, of which 945 met criteria for further analysis. PLWH were excluded from 59% pre-2018 versus 48% post-2018. After multivariate adjustment, NIH-funded trials (24% exclusion rate, p < 0.001), other funders (64% exclusion rate), and studies initiated post-2018 (48% exclusion rate, p < 0.001) were associated with inclusion, while CAR-T-related studies (62% exclusion rate, p < 0.05) were associated with exclusion.

Conclusions: Likely partly due to advocacy from ASCO, NCI, and NCCN, there was a significant decrease in exclusion among PLWH in US-based NHL clinical trials. Future research should analyze the safety and efficacy of immunotherapy in PLWH to foster inclusion and reduce stigma among physicians and researchers.

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来源期刊

Cancer Investigation 医学-肿瘤学

CiteScore

3.80

自引率

4.20%

发文量

审稿时长

8.5 months

期刊介绍： Cancer Investigation is one of the most highly regarded and recognized journals in the field of basic and clinical oncology. It is designed to give physicians a comprehensive resource on the current state of progress in the cancer field as well as a broad background of reliable information necessary for effective decision making. In addition to presenting original papers of fundamental significance, it also publishes reviews, essays, specialized presentations of controversies, considerations of new technologies and their applications to specific laboratory problems, discussions of public issues, miniseries on major topics, new and experimental drugs and therapies, and an innovative letters to the editor section. One of the unique features of the journal is its departmentalized editorial sections reporting on more than 30 subject categories covering the broad spectrum of specialized areas that together comprise the field of oncology. Edited by leading physicians and research scientists, these sections make Cancer Investigation the prime resource for clinicians seeking to make sense of the sometimes-overwhelming amount of information available throughout the field. In addition to its peer-reviewed clinical research, the journal also features translational studies that bridge the gap between the laboratory and the clinic.