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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
1.25g/㎡ d1, repeated every 21 days
2500IU/㎡ d1, total dose=\<3750IU, repeated every 21 days
75mg/㎡ d1-3, repeated every 21 days
Beijing Tongren Hospital
Beijing, China
RECRUITING2-year progression free survival (PFS) rate
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
Time frame: 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
Overall response rate (ORR)
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
Complete response rate (CRR)
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
2-year overall survial (OS) rate
OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
Time frame: From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
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20mg d1-4