Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma (SPIRIT-02)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Intervention / Treatment: Drug: Sintilimab with P-GEMOX Regimen; Drug: P-GEMOX Regimen

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cai Qingqing, MD.PhD; Phone Number: (020)87342823; Email: caiqq@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen Universitiy Cancer Center
      • Contact: Cai Qingqing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Sintilimab with P-GEMOX Regimen	Drug: Sintilimab with P-GEMOX Regimen; Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip; Other Names: Sintilimab, Pegaspargase, gemcitabine, oxaliplatin
Active Comparator: control group; P-GEMOX Regimen	Drug: P-GEMOX Regimen; Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip; Other Names: Pegaspargase, gemcitabine, oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR rate	objective response rate	Up to 4 years
CR rate	complete response rate	Up to 4 years
OS	overall survival	Up to 4 years
Adverse events	The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)	Up to 4 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 28, 2024
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Oxaliplatin; Asparaginase; Pegaspargase; Gemcitabine
• Other Study ID Numbers: B2024-475-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No