Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
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 sec
| Condition(s) | Extranodal NK/T-cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-05-20 |
| NCT ID | NCT06824883 |
| Official listing | https://clinicaltrials.gov/study/NCT06824883 |