Clinical trial NCT06824883: Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
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)
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From date of enrollment until documented disease progression or death of any reason (up to 3 years).
measure: Overall survival
timeFrame: From date of enrollment until documented death of any reason (up to 3 years).
measure: Overall response rate
timeFrame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).
measure: Adverse event
timeFrame: From enrollment till 28 days post the last induction cycle.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: