Optimization of the First-line Therapy of T-cell Lymphomas

N.N. Petrov National Medical Research Center of Oncology0 个研究点目标入组 114 人开始时间: 2013年10月1日最近更新: 2025年12月2日

干预措施

试验速览

阶段: 3 期
状态: Enrolling By Invitation
发起方
入组人数: 114
主要终点: complete response rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

There is no data comparing the effectiveness of the 4 most relevant first-line therapy programs for peripheral T-cell lymphomas (CHOEP, CHOP, CHEP-BV, CHP-BV) in a single study.

For the first time, the effectiveness and toxicity of various first-line PTCL therapy programs in patients with T-cell lymphoma will be analyzed in the conditions of a single medical center of the N.N.Petrov National Research Medical Center of Oncology and optimal therapeutic tactics will be determined, taking into account significant prognostic factors based on effectiveness and toxicity a specific chemotherapy regimen.

详细描述

A non-randomized retrospective cohort study with prospective inclusion is planned.

Patients with a confirmed diagnosis of PTCL (who meet the inclusion criteria) who were treated at the same center of the NN Petrov National Medical Cancer Research Center from 2013 to 2024, depending on the first-line therapy regimen, will be included in the retrospective part of the study and divided into 2 groups: Group 1: CHOEP regimen Group 2: CHOP regimen

The prospective part of this study is planned to include patients (who meet the inclusion criteria) who are hospitalized at the NN Petrov National Medical Cancer Research Center for treatment from January 2024 to January 2027. Patients will be divided into 2 groups depending on the chemotherapy regimen:

Group 3: chemoimmunotherapy according to the CHP-BV regimen Group 4: chemoimmunotherapy according to the CHEP-BV regimen Based on the data from the medical documentation of patients, the main statistical indicators of the effectiveness of first-line treatment regimens will be calculated using objective methods for assessing the antitumor effect (PET CT, CT), the toxicity of each of the regimens will be assessed, as well as possible prognostic factors for all patient groups.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with newly diagnosed mature T-cell lymphomas
•absence of acute infectious diseases during treatment diseases, chronic diseases in the stage of decompensation
•Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

排除标准

•the presence of a history of other malignant neoplasms during the 5-year period before the start of first-line therapy, In addition to in situ neoplasms treated according to appropriate treatment protocols,
•there are acute infectious diseases and chronic diseases in the decompensation stage.