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Набор скоро начнётся NCT05909098

Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma

Фаза I / Фаза II С лечением NK Cell B-cell Lymphoma Recurrent B-cell Lymphoma Refractory

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: autologous NK cell.
Кому может быть актуально
Состояния в реестре: NK Cell, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Официальное название

Xiangyang No.1 People's Hospital, Hubei University of Medicine

Обзор

This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.

Подробное описание

This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.

Вмешательства

  • Комбинированный продукт autologous NK cell
    autologous NK cell

Первичные конечные точки

  • ORR [Срок оценки: up to 5 years of treatment]
Вторичные конечные точки (10)
  • CR [Срок оценки: up to 5 years of treatment]
  • PR [Срок оценки: up to 5 years of treatment]
  • SD [Срок оценки: up to 5 years of treatment]
  • PD [Срок оценки: up to 5 years of treatment]
  • CBR [Срок оценки: up to 5 years of treatment]
  • PFS [Срок оценки: up to 5 years of treatment]
  • DOR [Срок оценки: up to 5 years of treatment]
  • OS [Срок оценки: up to 5 years of treatment]
  • ECOG [Срок оценки: up to 5 years of treatment]
  • EORTC QLQ-C30 [Срок оценки: up to 5 years of treatment]

Критерии участия

Критерии включения

  • Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
  • Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
  • First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
  • ECOG scores were 0 to 2
  • Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
  • For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.
  • For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.
  • Volunteer to participate in the trial and sign the informed consent form.

Критерии исключения

  • Presence of bone marrow or/and central nervous system lymphoma.
  • Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
  • Combined with other malignancies.
  • Fever of non-disease-related origin within the last 5 days.
  • Presence of uncontrollable bacterial, fungal, viral or other infections.
  • Patients with HIV, TP positive
  • Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.
  • Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.
  • Received any form of organ transplantation, including allogeneic stem cell transplantation.
  • Presence of a serious psychiatric disorder.
  • Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.
  • Pregnant or lactating women.
  • The researchers deemed unsuitable for participation in this study. -

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • EC of Xiangyang No.1 People's Hospital Hubei University of Medicine — Hubei

Идентификаторы

NCT: NCT05909098 · Xiangyang1PH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗