RecruitingPhase 2NCT06824883

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

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


Sponsor

Peking Union Medical College Hospital

Enrollment

49 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of sintilimab (an immunotherapy drug), pegaspargase (a chemotherapy drug), and GemOx (gemcitabine plus oxaliplatin) for people with a rare and aggressive lymphoma called extranodal NK/T-cell lymphoma who have not yet received treatment. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with extranodal NK/T-cell lymphoma - You have not yet received any chemotherapy or immunotherapy for this cancer - Your organ function (liver, kidneys, blood counts) is within acceptable ranges - You are in reasonably good physical health (ECOG score 0–2) **You may NOT be eligible if...** - You have previously been treated with chemotherapy for this cancer - You have active hepatitis B or C infection - You have active autoimmune disease - You are pregnant or breastfeeding - You have serious heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImmunochemotherapy

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.


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06824883


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