Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma

Официальное название

A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer/T-Cell Lymphoma (SCENT-3)

Обзор

This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg/d on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).

Вмешательства

• Препарат SCA Induction followed by Response-Adapted Therapy
  Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose. Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 \[SCA\]). Cycle length is 21 days. Response-Adapted Consolidation: Patients achievi

Первичные конечные точки

• Complete Remission rate [Срок оценки: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.]

Вторичные конечные точки (6)

• objective response rate [Срок оценки: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.]
• Partial Remission (PR) rate [Срок оценки: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.]
• Progression-Free Survival [Срок оценки: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
• Duration of Response [Срок оценки: From date of first documented response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
• Overall Survival [Срок оценки: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.]
• Adverse Events [Срок оценки: From the date of informed consent and first dose of study drug up to 30 days (or 90 days for immune-related AEs) after the last dose of study treatment or completion of radiotherapy.]

Критерии участия

Критерии включения

• Willingness to participate in the clinical study.
• Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).
• Newly diagnosed ENKTL confirmed by histopathology at the study center.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• At least one evaluable or measurable lesion
• Ann Arbor stage I-II disease.
• PINK-E score ≥ 1.
• Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or abnormalities in cardiac, pulmonary, hepatic, renal, or thyroid function, and no immunodeficiency.

Критерии исключения

• Aggressive natural killer cell leukemia.
• Presence of hemophagocytic syndrome.
• Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
• Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
• Patients with active chronic hepatitis B or active hepatitis C.

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

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07542912 · SCENT-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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