drugset / Trial / NCT02560441
Trial of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Phase 2
Unknown
Chinese Academy of Medical Sciences
307 Hospital of PLA · collabFirst Hospital of China Medical University · collabGuangdong Provincial People's Hospital · collabHebei Medical University Fourth Hospital · collabNanfang Hospital, Southern Medical University · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabQilu Hospital of Shandong University · collabShandong Cancer Hospital and Institute · collabShanxi Dayi Hospital · collabShanxi Province Cancer Hospital · collabThe Second Affiliated Hospital of Dalian Medical University · collabTianjin Medical University Cancer Institute and Hospital · collabXuzhou Medical University · collabZhangzhou Municipal Hospital of Fujian Province · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage II disease (only referring to patients with the invasion of Waldeyer's ring and cervical lymph nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy followed by radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both arms are 3 cycles. And the chemotherapy is repeated every 3 weeks.. The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is repeated every 3 weeks.
Timeline
- Start
- 2015-09
- Primary completion
- 2022-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg | Intravenous |
| Subject | Ifosfamide | Small molecule | 1.2 g | Intravenous |
| Subject | Pegaspargase | Protein / enzyme biologic | 2000 iu | Intramuscular |