Treatment for untreated extranodal NK/T-cell lymphoma using a combination of drugs
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
This study is testing a new combination of drugs to see if it can help people with untreated extranodal NK/T-cell lymphoma feel better and improve their chances of survival.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | sintilimab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06824883 on ClinicalTrials.gov |
What this trial studies
This phase 2 study evaluates the safety and efficacy of a combination treatment involving sintilimab, pegaspargase, and the P-P-GEMOX regimen (gemcitabine and oxaliplatin) for patients with untreated extranodal NK/T-cell lymphoma (ENKTL). The study aims to determine the complete response rate as the primary endpoint, while also assessing overall response rate, progression-free survival, overall survival, and adverse events as secondary endpoints. Participants will be closely monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of extranodal NK/T-cell lymphoma and specific risk factors.
Not a fit: Patients with aggressive NK-cell leukemia or central nervous system lymphoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with untreated ENKTL.
How similar studies have performed: Other studies have shown promise with similar immunochemotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wei Zhang
- Email: vv1223@vip.sina.com
- Phone: 010-69155760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.