drugset / Trial / NCT01501149
Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ
Phase 4
Unknown
80 enrolled
Mingzhi Zhang
Cancer Hospital of Guizhou Province · collabQingdao University · collabSecond Hospital of Shanxi Medical University · collabShanxi Province Cancer Hospital · collabThe First Affiliated Hospital of Henan University of Traditional Chinese Medicine · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWuhan TongJi Hospital · collabWuhan University · collabXinyang Central Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2011-01
- Primary completion
- 2015-12
- Completion
- 2019-05
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 240 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 15 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 1.5 g | Intravenous |
| Subject | Methotrexate | Small molecule | 2 g | Intravenous |
| Subject | Pegaspargase | Protein / enzyme biologic | 2500 iu | Intramuscular |
| Subject | asparaginase | Protein / enzyme biologic | 6000 unknown | Intravenous |