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

Phase 2

Recruiting

• Conditions: Extranodal NK/T-cell Lymphoma
• Interventions: Drug: Immunochemotherapy

• Registration Number: NCT06824883
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-20
• Status Verified: 2025-01
• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-05-20
• Study Completion: 2027-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P-P-GemOx arm	Immunochemotherapy	Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen

Primary Outcome Measures

Name	Time	Method
Complete response rate (CRR)	Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)	Treatment responses were assessed according to the 2014 Lugano classification criteria.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From date of enrollment until documented disease progression or death of any reason (up to 3 years).	Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
Overall survival	From date of enrollment until documented death of any reason (up to 3 years).	Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Overall response rate	Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).	The ORR was defined as the proportion of patients with CR or PR.
Adverse event	From enrollment till 28 days post the last induction cycle.	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China