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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Treated with gemcitabine, pegaspargase, etoposide and dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1000mg/㎡,d1,4 ivdrip |
| |
| Pegaspargase |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | 24 weeks ±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | 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 |
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Inclusion Criteria:
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.
• Other experimental drugs are being used.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Wang, M.D. | Contact | +861058268442 | wangliangtrhos@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang Wang, M.D. | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C042705 | pegaspargase |
| D005047 | Etoposide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
2500IU/㎡, maximum dose less than 3750IU |
|
| Etoposide | Drug | 100mg/㎡,d1-3 ivdrip |
|
| Dexamethasone | Drug | 20mg/d d1-4 ivdrip |
|
| up to 1year after enrollment |
| 1-year overall survival rate | time from date of enrollment to date death of any reason | up to 1year after enrollment |
| D009369 |
| Neoplasms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |