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Rituximab-combined anthracycline-free chemotherapy in newly diagnosed paediatric and adolescent patients with non-high-risk aggressive mature B cell lymphoma: protocol for a single-arm, open-label, multicentre, phase II study (the Japan Childrens Cancer G

Por: Sekimizu · M. · Fukano · R. · Koga · Y. · Mitsui · T. · Fujita · N. · Mori · T. · Hori · D. · Tanaka · M. · Ohki · K. · Iwafuchi · H. · Nakazawa · A. · Mori · T. · Kobayashi · R. · Hashimoto · H. · M. Saito · A. · Kamei · M. · on behalf of Lymphoma Committee of Japan Childrens Cancer G
Introduction

Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.

Methods and analysis

We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I – completely resected, stage II abdominal) and intermediate-risk (stages I and II – incompletely resected; stage II – resected, other than abdominal; stage III with LDH x upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (

Ethics and dissemination

This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.

Study registration

Japan Registry of Clinical Trials, jRCTs041210104.

Perceived quality of life and associated factors in long COVID syndrome among older Brazilians: A cross‐sectional study

Abstract

Aims and objectives

This paper aims to: (a) determine the personal, sociodemographic, clinical, behavioural, and social characteristics of older Brazilians with clinical evidence of long COVID; (b) evaluate perceived quality of life and determine its association with personal, sociodemographic, behavioural, clinical and social variables; and (c) assess significant predictors of high perceived QoL.

Background

Given the inherent vulnerabilities of the ageing process, the older people are an at-risk group for both contagion of SARS-CoV-2 and the perpetuation of residual symptoms after infection, the so-called long COVID or post-COVID syndrome.

Design

A cross-sectional survey design using the STROBE checklist.

Methods

Brazilian older people with long COVID syndrome (n = 403) completed a phone survey measuring personal, sociodemographic, behavioural, clinical, and social characteristics, and perceived Quality of Life (QoL). Data were collected from June 2021–March 2022. A multiple linear regression model was performed to identify salient variables associated with high perceived QoL.

Results

The mean age of participants was 67.7 ± 6.6 years old. The results of the multivariate regression model showed that race, home ownership, daily screen time, musculoskeletal and anxiety symptoms, and work situation were the significant predictors of QoL among COVID-19 survivors.

Conclusions

Knowledge about the persistence of physical, emotional, and social symptoms of COVID-19 can help nurses and other healthcare providers to improve the management of survivors, bringing benefits to the whole society.

Relevance to clinical practice

Given the novelty of long-COVID and its heterogeneous trajectory, interventions focusing on the repercussions and requirements unique to more vulnerable older persons should be developed and these aspects should be included in public health recommendations and policymakers' concerns.

Patient or Public Contribution

No patient or public contribution was required to design, to outcome measures or undertake this research. Patients/members of the public contributed only to the data collection.

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