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NCT Number: NCT06583083

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

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.

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Key information

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen Universitiy Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Cai Qingqing

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sintilimab with P-GEMOX Regimen

Drug

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

Other names: Sintilimab, Pegaspargase, gemcitabine, oxaliplatin

P-GEMOX Regimen

Drug

Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Other names: Pegaspargase, gemcitabine, oxaliplatin

Primary outcomes

  1. PFS

    Time frame: Up to 4 years

    progression free survival

Secondary outcomes

  1. ORR rate

    Time frame: Up to 4 years

    objective response rate

  2. CR rate

    Time frame: Up to 4 years

    complete response rate

  3. OS

    Time frame: Up to 4 years

    overall survival

  4. Adverse events

    Time frame: Up to 4 years

    The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Cai Qingqing, MD.PhD

CONTACT

[email protected]

(020)87342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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)

Acronym: SPIRIT-02

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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