Clinical trial · Interventional
Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunochemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- P-P-GemOx arm
- description
- Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen
- interventionNames
- Drug: Immunochemotherapy
Primary outcomes (1)
- measure
- Complete response rate (CRR)
- timeFrame
- Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)
- description
- Treatment responses were assessed according to the 2014 Lugano classification criteria.
Secondary outcomes (4)
- measure
- Progression-free survival (PFS)
- timeFrame
- From date of enrollment until documented disease progression or death of any reason (up to 3 years).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available