Extranodal NK/T-cell Lymphoma
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients
Interventions
DRUGGemcitabine
1000mg/㎡，d1,4 ivdrip
DRUGPegaspargase
2500IU/㎡, maximum dose less than 3750IU
DRUGEtoposide
100mg/㎡，d1-3 ivdrip
DRUGDexamethasone
20mg/d d1-4 ivdrip
Sponsors
Beijing Tongren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria. * refractory or relapsed after initial remission, or stage III-IV de novo patients * PET/CT or CT/MRI with at least one objectively evaluable lesion. * General status ECOG score 0-3 points. * The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking. * Sign the informed consent form
Exclusion criteria
Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded. Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months. Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months. • Other experimental drugs are being used.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 24 weeks ±7 days | evaluated by PET-CT and MRI, according to Lugano 2014 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate | 24 weeks ±7 days | evaluated by PET-CT and MRI, according to Lugano 2014 criteria |
| 1-year progression free survival rate | up to 1year after enrollment | time from date of enrollment to date of disease progression, death of any reason, whichever comes first |
| 1-year overall survival rate | up to 1year after enrollment | time from date of enrollment to date death of any reason |
Countries
China
Contacts
Primary ContactLiang Wang, M.D.
Outcome results
None listed