Status:
RECRUITING
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06583083
Start Date
October 22 2024
End Date
August 28 2026
Last Update
October 23 2024
Active Locations (1)
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1
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, China, 510060