RecruitingPhase 2NCT06583083

Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma

A Multicenter, Phase 2, Randomized Trial of Sintilimab (PD-1 Antibody) With P-GEMOX Versus the P-GEMOX Regimen in the Teatment of Newly Diagnosed Advanced-stage Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (SPIRIT-02)


Sponsor

Sun Yat-sen University

Enrollment

84 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment approaches for advanced extranodal natural killer/T-cell lymphoma (ENKTL) — a rare and aggressive type of lymphoma (blood cancer) that often affects the nose and upper airway. The trial tests whether adding sintilimab (an immunotherapy drug) to the P-GEMOX chemotherapy regimen improves survival. **You may be eligible if...** - You have been diagnosed with ENKTL confirmed by tissue biopsy - Your disease is at an advanced stage - You have at least one measurable tumor - You are 18 or older with an expected survival of more than 3 months - Your organ function and blood counts are adequate **You may NOT be eligible if...** - You have active autoimmune disease - You have received prior treatment for ENKTL - You have serious heart, liver, or kidney problems 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

DRUGSintilimab with P-GEMOX Regimen

Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

DRUGP-GEMOX Regimen

Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip


Locations(1)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, Guangdong, China

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NCT06583083


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