Extranodal NK/T-cell Lymphoma, Nasal Type
Conditions
Keywords
extranodal NK/T-cell lymphoma, gemcitabine, etoposide, dexamethasone, pegaspargase, hemophagocytic syndrome
Brief summary
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).
Detailed description
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.
Interventions
DRUGgemcitabin
1.25g/㎡ d1, repeated every 21 days
DRUGPegaspargase
2500IU/㎡ d1, total dose=\<3750IU, repeated every 21 days
DRUGEtoposide
75mg/㎡ d1-3, repeated every 21 days
DRUGDexamethasone
20mg d1-4
Sponsors
Beijing Tongren Hospital
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
* 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. * 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 |
|---|---|---|
| 2-year progression free survival (PFS) rate | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | evaluated every 2 cycles of treamtent, up to one month after the end of treatment | evaluated by PET-CT and MRI, according to Lugano 2014 criteria |
| Complete response rate (CRR) | evaluated every 2 cycles of treamtent, up to one month after the end of treatment | evaluated by PET-CT and MRI, according to Lugano 2014 criteria |
| 2-year overall survial (OS) rate | From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months | OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first. |
Countries
China
Outcome results
None listed