drugset / Trial / NCT04230330
Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors will be excluded from this study. Patients who have a complete response or good partial response to nivolumab during initial phase will continue to be treated with nivolumab. Patients who have a partial response, stable disease, and progressive disease to nivolumab during initial phase will be treated with the combination of nivolumab and GDP/L-asparaginase.
Timeline
- Start
- 2019-12-12
- Primary completion
- 2020-06-12
- Completion
- 2020-06-12
Publications
- Background Li X, Cheng Y, Zhang M, Yan J, Li L, Fu X, Zhang X, Chang Y, Sun Z, Yu H, Zhang L, Wang X, Wu J, Li Z, Nan F, Tian L, Li W, Young KH. Activity of pembrolizumab in relapsed/refractory NK/T-cell lymphoma. J Hematol Oncol. 2018 Jan 31;11(1):15. doi: 10.1186/s13045-018-0559-7.
- Background Kwong YL, Chan TSY, Tan D, Kim SJ, Poon LM, Mow B, Khong PL, Loong F, Au-Yeung R, Iqbal J, Phipps C, Tse E. PD1 blockade with pembrolizumab is highly effective in relapsed or refractory NK/T-cell lymphoma failing l-asparaginase. Blood. 2017 Apr 27;129(17):2437-2442. doi: 10.1182/blood-2016-12-756841. Epub 2017 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | asparaginase | Protein / enzyme biologic | 6000 unknown | Intravenous |