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Набор скоро начнётся NCT06665737

Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients

Фаза IV С лечением Non-Hodgkin's Lymphoma (NHL) Granulocyte Colony Stimulating Factor Febrile Neutropenia (FN) Myelosuppression Adult

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Early receiving G-CSF group, Late receiving G-CSF group.
Кому может быть актуально
Состояния в реестре: Non-Hodgkin's Lymphoma (NHL), Granulocyte Colony Stimulating Factor, Febrile Neutropenia (FN), Myelosuppression Adult. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study

Обзор

The goal of this clinical trial is to Primary Objectives: 1. To compare the incidence of febrile neutropenia in patients with non-Hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (G-CSF) during standard chemotherapy in a multicenter study 2. To determine the incidence of leukopenia and neutropenia in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy in a multicenter study Secondary Objectives: 1. To determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy. 2. To determine the quality of life of patients with non-Hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia Researchers will compare the outcome between patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.

Подробное описание

This study aims to analyze the impact of the timing of granulocyte colony-stimulating factor (G-CSF) administration on the prevention of febrile neutropenia (FN) in non-Hodgkin's lymphoma patients undergoing standard chemotherapy. G-CSF is a growth factor that stimulates the production of white blood cell in order to fighting infection. When non-Hodgkin's lymphoma patients receive chemotherapy for eradicating cancer cells. They also have collateral damage those white blood cells and other hematopoietic cell lines.

All patients received standard chemotherapy regimens once every four weeks. The study will compare the efficacy of early G-CSF administration, or late administration, after each course of chemotherapy.

The primary endpoint is the incidence of FN in each chemotherapy course. At the end of each chemotherapy course, patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for FN events.

Secondary endpoints include the incidence of myelosuppression and quality of life, assessed during outpatient and emergency department visits.

Вмешательства

  • Препарат Early receiving G-CSF group
    Early receiving G-CSF group will be given within 72 hours post chemotherapy
  • Препарат Late receiving G-CSF group
    Late receiving G-CSF group will be given after 72 hours post chemotherapy

Первичные конечные точки

  • Incidence of febrile neutropenia [Срок оценки: One year]
  • Incidence of leukopenia and neutropenia [Срок оценки: One year]
Вторичные конечные точки (3)
  • Incidence of grade 3 or 4 of myelosuppression [Срок оценки: One year]
  • Time of visits to outpatient (OPD) and emergency clinics (ER) [Срок оценки: One year]
  • Quality of life (QoL) after chemotherapy [Срок оценки: One year]

Критерии участия

Критерии включения

  • Aged 18 years or old
  • Confirmed lymphoma undergoing standard chemotherapy
  • Signed an approval informed consent
  • Has a good understanding of Thai
  • Available for follow-up after chemotherapy

Критерии исключения

  • Pregnancy or lactation
  • Serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases
  • Contraindication to chemotherapy or G-CSF administration
  • Antibiotic use within 1 week prior to enrollment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Таиланд · 3 центра
  • Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University — Bangkok
  • Rajavithi Hospital — Bangkok
  • Internal Medicine Unit, Pranongklao Hospital — Nontaburi

Идентификаторы

NCT: NCT06665737 · 205/2567 · Rajavithi Hospital

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗