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| Name | Class |
|---|---|
| Second Hospital of Shanxi Medical University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Wuhan University | OTHER |
| Wuhan TongJi Hospital |
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The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDGP regiment | Experimental | DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment |
|
| SMILE Regiment | Experimental | Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) | Drug | DDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | up to end of follow-up-phase (approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | 21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles. | every 6 weeks,up to completion of treatment(approximately 18 weeks ) |
| overall survival | up to the date of death (approximately 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi Zhang, Pro,Dr | Contact | 13838565629 | mingzhi_zhang@126.com | |
| Mingzhi Zhang, Pro,Dr | Contact | mingzhi_zhang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingzhi Zhang, Pro，Dr | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35708709 | Derived | Wang X, Zhang L, Liu X, Li X, Li L, Fu X, Sun Z, Wu J, Zhang X, Yan J, Chang Y, Nan F, Zhou Z, Wu X, Tian L, Ma M, Li Z, Yu H, Zhu L, Wang Y, Shi C, Feng X, Li J, Ding M, Zhang J, Dong M, Xue H, Wang J, Zou L, Su L, Wu J, Liu L, Bao H, Zhang L, Guo Y, Guo S, Lu Y, Young KH, Li W, Zhang M. Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1035-1041. doi: 10.1001/jamaoncol.2022.1968. | |
| 31118779 |
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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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| OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Qingdao University | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
| Xinyang Central Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
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| Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna） | Drug | MTX,2g/m2 (20% ivgtt（intravenously guttae）,2h;80% ivgtt,4h), d1;DEX,40mg,ivgtt,d2-4;IFO,1.5g/m2,ivgtt,d2-4;L-ASP,6000U/m2,ivgtt,d3-9;VP-16,100mg/m2,ivgtt,d2-4; Mesna,0、4、8h after IFO, 240mg/m2,iv,d2-4.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles. |
|
|
| median survival time | 24 months |
| Derived |
| Zhao Q, Fan S, Chang Y, Liu X, Li W, Ma Q, Li Y, Wang Y, Zhang L, Zhang M. Clinical efficacy of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) in the initial treatment of advanced stage (stage III-IV) extranodal NK/T-cell lymphoma, and its correlation with Epstein-Barr virus. Cancer Manag Res. 2019 Apr 24;11:3555-3564. doi: 10.2147/CMAR.S191929. eCollection 2019. |
| 27384676 | Derived | Zhang L, Jia S, Ma Y, Li L, Li X, Wang X, Fu X, Ma W, Qin Y, Li W, Wu J, Sun Z, Zhang X, Nan F, Chang Y, Li Z, Zhang D, Wang G, Yan J, Su L, Wang J, Xue H, Young KH, Zhang M. Efficacy and safety of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) regimen in newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma: interim analysis of a phase 4 study NCT01501149. Oncotarget. 2016 Aug 23;7(34):55721-55731. doi: 10.18632/oncotarget.10124. |
| 27060152 | Derived | Li X, Cui Y, Sun Z, Zhang L, Li L, Wang X, Wu J, Fu X, Ma W, Zhang X, Chang Y, Nan F, Li W, Su L, Wang J, Xue H, Zhang M. DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China. Clin Cancer Res. 2016 Nov 1;22(21):5223-5228. doi: 10.1158/1078-0432.CCR-16-0153. Epub 2016 Apr 8. |
| D009369 |
| Neoplasms |