A Phase 2 interventional study of Gemcitabine and Pegaspargase in Extranodal NK/T-cell Lymphoma, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by Beijing Tongren Hospital · Phase 2, Interventional, and Treatment
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
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 15 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
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.
Treated with gemcitabine, pegaspargase, etoposide and dexamethasone
Drug: Gemcitabine · Drug: Pegaspargase · Drug: Etoposide · Drug: Dexamethasone
1000mg/㎡，d1,4 ivdrip
2500IU/㎡, maximum dose less than 3750IU
100mg/㎡，d1-3 ivdrip
20mg/d d1-4 ivdrip
overall response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
complete response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
1-year progression free survival rate
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
Time frame: up to 1year after enrollment
1-year overall survival rate
time from date of enrollment to date death of any reason
Time frame: up to 1year after enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Beijing Tongren Hospital