Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

Официальное название

A Single-arm, Phase 2 Study of Sintilimab, Pegaspargase Combined with Gemcitabine and Oxaliplatin (P-P-GEMOX) Regimen for Newly Diagnosed Extranodal NK/T-Cell Lymphoma

Обзор

This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.

Вмешательства

• Препарат Immunochemotherapy
  P-P-GemOx regimen Sintilimab 200mg iv D1; Pegaspargase 3750U im D1; GemOx regimen: Gemcitabine 1000mg/m2 iv D1, Oxaliplatin 100mg/m2 iv D1 This regimen is administered every 3 weeks. For patients with stage I-II (localized) disease: A sandwich approach incorporating radiotherapy is employed. Patients initially receive 2 cycles of the P-P-GemOx regimen. If the interim evaluation demonstrates a complete response (CR) or partial response (PR), patients will proceed to intensity-modulated radiothe

Первичные конечные точки

• Complete response rate (CRR) [Срок оценки: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)]

Вторичные конечные точки (4)

• Progression-free survival (PFS) [Срок оценки: From date of enrollment until documented disease progression or death of any reason (up to 3 years).]
• Overall survival [Срок оценки: From date of enrollment until documented death of any reason (up to 3 years).]
• Overall response rate [Срок оценки: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).]
• Adverse event [Срок оценки: From enrollment till 28 days post the last induction cycle.]

Критерии участия

Критерии включения

• Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) by the study center.
• Age between 18 and 75 years.
• At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenase (LDH); Baseline EBV-DNA > 500 copies/mL.
• ECOG performance status of 0 to 3.
• Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g/L.
• Adequate organ function: Alanine aminotransferase (ALT) < 3 × the upper limit of normal (ULN); Total bilirubin (TBil) < 1.5 × ULN; Serum creatinine < 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) > 50%.

Критерии исключения

• Aggressive NK-cell leukemia.
• Central nervous system lymphoma.
• History of any of the following within 6 months: Acute myocardial infarction; Unstable angina; Congestive heart failure; Uncontrolled symptomatic arrhythmia; Complete left bundle branch block; Second- or third-degree atrioventricular block; Long QT syndrome or corrected QT interval (QTc) > 480 ms.
• Uncontrolled active infection.
• Pregnant or breastfeeding women.

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

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06824883 · PUMCH-NHL-019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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