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Recruiting NCT06583083

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

Phase II Interventional Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab with P-GEMOX Regimen, P-GEMOX Regimen.
Who it may be relevant to
Registry conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Interventions

  • Drug Sintilimab with P-GEMOX Regimen
    Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip
  • Drug P-GEMOX Regimen
    Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Primary outcome measures

  • PFS [Time frame: Up to 4 years]
Secondary outcome measures (4)
  • ORR rate [Time frame: Up to 4 years]
  • CR rate [Time frame: Up to 4 years]
  • OS [Time frame: Up to 4 years]
  • Adverse events [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

  • Pathologically diagnosed with ENKTL.
  • Advanced stage.
  • Has at least one measurable or assessable lesion.
  • Age > 18 years, no gender restrictions, with an expected survival of more than 3 months.
  • Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
  • Adequate organ and bone marrow function.

Exclusion criteria

  • Aggressive NK-cell leukemia.
  • Central nervous system involvement.
  • Patients with significant dysfunction of vital organs.
  • History of allergy to the investigational drug, similar drugs, or excipients.
  • Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
  • Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
  • Active infection, excluding fever related to tumor-associated B symptoms.
  • Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen Universitiy Cancer Center — Guangzhou

Identifiers

NCT: NCT06583083 · B2024-475-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗