Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06824883

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

Led by Peking Union Medical College Hospital · Updated on 2025-02-13

49

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 62; 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) 651.5 �d7 10�b9/L (651.0 �d7 10�b9/L in cases with bone marrow involvement); Platelet count (PLT) 6580 �d7 10�b9/L (6550 �d7 10�b9/L in cases with bone marrow involvement); Hemoglobin (HGB) 6580 g/L.
  • Adequate organ function: Alanine aminotransferase (ALT) < 3 �d7 the upper limit of normal (ULN); Total bilirubin (TBil) < 1.5 �d7 ULN; Serum creatinine < 1.5 �d7 ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) > 50%.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

W

Wei Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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