Меню
Идёт набор NCT07000617

A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma

Фаза II С лечением NK/T Cell Lymphoma

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: DAPT regimen plus radiotherapy.
Кому может быть актуально
Состояния в реестре: NK/T Cell Lymphoma. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The goal of this clinical trial is to learn if the regimen of dexamethasone, azacitidine, pegaspargase and tislelizumab (DAPT regimen) combined with radiotherapy works to treat stage I or II NK/T cell lymphoma in adults. It will also learn about the safety of the DAPT regimen. The main questions it aims to answer are: What are the efficacy of the DAPT regimen plus radiotherapy in participants with extranodal NK/T-cell lymphoma? What medical problems do participants have when taking the DAPT regimen? Participants will: Receive the DAPT regimen every 21 days for 6 cycles and radiotherapy Visit the clinic according to clinical trial requirement for checkups and tests Receive blood tests and radiological imaging tests according to the clinical trial requirement

Вмешательства

  • Препарат DAPT regimen plus radiotherapy
    Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen is administered as follows: dexamethasone 10mg intravenously on days1-3, azacitidine 100mg subcutaneously on days 1-5, pegaspargase 2500IU/m2 intramuscularly on day 1, and tislelizumab 200mg intravenously on day 6, repeated every 21 days. Concurrent radiotherapy given to the tumor sites is started after 2 cycles of DAPT regimen. The specific doses and methods of radiotherapy are in accordance with the clinic

Первичные конечные точки

  • Complete response rate [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (4)
  • Objective response rate [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • 2-year progression-free survival rate [Срок оценки: From enrollment to 2 years after the end of treatment]
  • 2-year overall survival rate [Срок оценки: From enrollment to 2 years after the end of treatment]
  • Adverse events [Срок оценки: From enrollment to the end of treatment at 1 month]

Критерии участия

Критерии включения

  • Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
  • Age ≥18 years
  • Ann Arbor stage I or II
  • Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
  • ECOG-PS 0\~2
  • Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/L and hemoglobin ≥90g/L
  • Expected survival of at least 3 months
  • Capable of understanding the content of this study, agreeing to participate in this study and signing the informed consent.

Критерии исключения

  • Unconfirmed pathological diagnosis of NK/T-cell lymphoma
  • Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
  • Patients with clinically significant prolonged QTc interval (>470ms in males, >480ms in females), ventricular tachycardia, atrial fibrillation, second or third degree atrioventricular block, acute myocardial infarction, congestive heart failure, severe or symptomatic coronary artery disease requiring medical treatment.
  • Patients with large amount of pericardial effusions shown by echocardiogram.
  • Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
  • Patients with severe active bleeding.
  • Patients with pulmonary embolism, intracranial hemorrhage or acute cerebral infarction.
  • Patients with active infectious disease.
  • Patients who are mentally disabled or unable to understand or sign the informed consent form.
  • Patients with other conditions judged as ineligible for this study by the investigators.

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 · 3 центра
  • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking U — Пекин
  • Peking University Cancer Hospital — Пекин
  • Peking University International Hospital — Пекин

Идентификаторы

NCT: NCT07000617 · 2024-1-2151

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗