Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

NCT06824883 | Recruiting Phase 2

• 1 other identifier: PUMCH-NHL-019
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Extranodal NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CRR)

  Treatment responses were assessed according to the 2014 Lugano classification criteria.

  Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)

Secondary Outcomes (4)

• Progression-free survival (PFS)

  From date of enrollment until documented disease progression or death of any reason (up to 3 years).

• Overall survival

  From date of enrollment until documented death of any reason (up to 3 years).

• Overall response rate

  Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).

• Adverse event

  From enrollment till 28 days post the last induction cycle.

Study Arms (1)

P-P-GemOx arm

EXPERIMENTAL

Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen

Drug: Immunochemotherapy

Interventions

Immunochemotherapy DRUG

P-P-GemOx regimen Sintilimab 200mg iv D1; Pegaspargase 3750U im D1; GemOx regimen: Gemcitabine 1000mg/m2 iv D1, Oxaliplatin 100mg/m2 iv D1 This regimen is administered every 3 weeks. For patients with stage I-II (localized) disease: A sandwich approach incorporating radiotherapy is employed. Patients initially receive 2 cycles of the P-P-GemOx regimen. If the interim evaluation demonstrates a complete response (CR) or partial response (PR), patients will proceed to intensity-modulated radiotherapy (IMRT). Following radiotherapy, an additional 2 cycles of the P-P-GemOx regimen are administered. For patients with stage III-IV (advanced) disease. Patients are planned to receive 6 cycles of the P-P-GemOx regimen. For those achieving CR or PR following 6 cycles of immunochemotherapy, subsequent treatment options include autologous hematopoietic stem cell transplantation (auto-HSCT) or PD-1 monoclonal antibody maintenance therapy, determined based on age and overall physical condition.

P-P-GemOx arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Wei Zhang

CONTACT

010-69155760; vv1223@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: May 20, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)