BrEto-TCL - Defining the Role of Brentuximab and Etoposide for Optimizing First-line Therapy of T-cell Lymphomas

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Doxorubicin
  doxorubicin 50 mg/m2, day 1
• Препарат Vincristine
  vincristine 1.4 mg/m2, (maximum dose 2 mg) day 1
• Препарат Etoposide
  Etoposide 100 mg/m2, 1-3 days
• Препарат cyclophosphamide
  cyclophosphamide 750 mg/m2, day 1
• Препарат Prednisone
  prednisone 100 mg, 1-5 days
• Препарат Brentuximab Vedotin (Bv)
  brentuximab vedotin 1.8 mg / kg, day 1

Первичные конечные точки

• complete response rate [Срок оценки: Up to 8 months]

Вторичные конечные точки (3)

• Incidence of Adverse Events (AEs) [Срок оценки: Up to 8 months]
• Progression-free Survival [Срок оценки: up to 1 year]
• Overall Survival (OS) [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07258680 · BrEto-TCL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗