Treatment for untreated extranodal NK/T-cell lymphoma using a combination of drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Zhang
• Email: vv1223@vip.sina.com
• Phone: 010-69155760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.