NK/T Cell Lymphoma Nos
Conditions
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)
Interventions
DRUGsintilimab,pegaspargase,gemcitabine,oxaliplatin
All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission (CR) rate | 2years |
| overall response rate (ORR) | 2years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed