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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma

Treatments: Drug: Immunochemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06824883

PUMCH-NHL-019

Details and patient eligibility

About

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.

Enrollment: 49 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

P-P-GemOx arm

Experimental group

Description:

Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen

Treatment:

Drug: Immunochemotherapy