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临床试验/CTRI/2024/12/078777
CTRI/2024/12/078777尚未招募不适用

Prevalence and correlation of infusion-related reactions with haematological and demographic factors following the first dose of Rituximab infusion

Manipal Acedemy of Higher Education1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Prevalence and types of infusion-related reactions following the first dose of rituximab.

研究概览

简要总结

After obtaining IEC clearance., we will register under CTRI, once we receive the approval from CTRI the study will be started by including all adult patients (≥18 years) treated in KMC Manipal with the first dose of Rituximab for any indication will be enrolled. Patient’s demographic factors like age, sex, performance status, comorbidity status, body surface -area, and body mass index; hematological parameters like- white blood cell count, absolute lymphocyte count, absolute neutrophil count, LDH, and hemoglobin; tumor-related factors like -type, grade, stage of lymphoma, B-symptoms, IPI, bulky disease  (> 10 cm ), bone marrow involvement, number of Extranodal sites, and LDH levels. Treatment-related factors like the type of chemotherapy, type of infusion-related reaction, defined as any adverse event occurring during or within 24 hours of rituximab infusion, time of onset of reaction, type of intervention, CTCAE grading, and consequences post-intervention, will be recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients of any malignancy receiving rituximab-based chemotherapy.

排除标准

  • Benign conditions Non hematological malignancies Prior Rituximab administration.

结局指标

主要结局

Prevalence and types of infusion-related reactions following the first dose of rituximab.

时间窗: one time point

次要结局

  • Correlation of infusion-related reactions with total leucocyte counts, other hematological parameters, demographic factors and tumor-related factors(one time point)

研究者

发起方
Manipal Acedemy of Higher Education
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Karthik S Udupa

Manipal Acedemy of Higher Education

研究点 (1)

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