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

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)

• ClinicalTrials.gov (NIH, США)

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