drugset / Trial / NCT02918747
PEG-ASP+Gemoxd vs. PEG-ASP+CHOP as First-line Chemotherapy to Treatment NK/T-cell Lymphoma With Early Stage
RandomizedParallel-groupOpen-labelTreatment
Summary
Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study to compare the efficacy of these two regimens. This prospective pilot study to compare the efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for stage IE to IIE ENKTL.
Timeline
- Start
- 2016-09
- Primary completion
- 2021-09
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 15 mg | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Pegaspargase | Protein / enzyme biologic | 2000 unknown | Intramuscular |
| Comparator | Prednisone | Other / unclassified | 60 mg/m2 | Oral |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |