Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
Phase 2
Recruiting
- Conditions
- NK/T Cell Lymphoma Nos
- Interventions
- Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin
- Registration Number
- NCT04127227
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
- newly diagnosed stage III/IV patients;
- at least one evaluable lesion；
- ECOG PS 0-2;
- 18-75 years; without other malignancy;
- proper functioning of the major organs.
Exclusion Criteria
- hemophagocytic syndrome or aggressive NK cell leukemia;
- involvement of central nervous system;
- previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sintilimab With P-GemOx sintilimab,pegaspargase,gemcitabine,oxaliplatin Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.
- Primary Outcome Measures
Name Time Method overall response rate (ORR) 2years complete remission (CR) rate 2years
- Secondary Outcome Measures
Name Time Method overall survival (OS) 2years progression survival (PFS) 2years disease-free survival (DFS) 2years bio-marker analysis 2years Correlation between programmed death-ligand 1 expression and efficacy
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China