Combining sintilimab with chemotherapy for advanced NK/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)
This study is testing if adding a new drug called sintilimab to chemotherapy can help people with advanced NK/T-cell lymphoma do better than with chemotherapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | sintilimab, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06583083 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of sintilimab, a PD-1 inhibitor, combined with the P-GEMOX chemotherapy regimen in patients with newly diagnosed advanced-stage extranodal NK/T-cell lymphoma. The study aims to determine if this combination can improve treatment outcomes compared to chemotherapy alone. Additionally, it will explore potential biomarkers that may predict patient responses to the treatment. The trial is designed as a randomized controlled trial to provide robust data on the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a pathologically diagnosed advanced-stage extranodal NK/T-cell lymphoma and at least one measurable lesion.
Not a fit: Patients with aggressive NK-cell leukemia, central nervous system involvement, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced NK/T-cell lymphoma, potentially improving survival rates.
How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in similar conditions, suggesting potential for success in this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Universitiy Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Cai Qingqing, MD.PhD
- Email: caiqq@sysucc.org.cn
- Phone: (020)87342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.