drugset / Trial / NCT02987244
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
Phase 1/2
Unknown
100 enrolled
Peking Union Medical College Hospital
Chinese PLA General Hospital · collabPeking University Cancer Hospital & Institute · collabPeking University First Hospital · collabPeking University Third Hospital · collabTianjin Medical University Cancer Institute and Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide， epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL.
Timeline
- Start
- 2016-03
- Primary completion
- 2020-03
- Completion
- 2023-03
Publications
- Background Dong M, Ning ZQ, Xing PY, Xu JL, Cao HX, Dou GF, Meng ZY, Shi YK, Lu XP, Feng FY. Phase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas. Cancer Chemother Pharmacol. 2012 Jun;69(6):1413-22. doi: 10.1007/s00280-012-1847-5. Epub 2012 Feb 24.
- Background Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23.
- Wang W, Zhang W, Su LP, Liu LH, Gao YH, Wang QS, Su H, Song YQ, Zhang HL, Shen J, Jing HM, Wang SY, Cen XN, Liu H, Liu AC, Li ZJ, Luo JM, He JX, Wang JW, O'Connor OA, Zhou DB. Efficacy of chidamide maintenance therapy versus autologous stem cell transplantation versus observation as a post-remission choice in the survival of adult patients with peripheral T-cell lymphoma: Post hoc analysis of a prospective, multicenter, phase 2 study in China. Ann Hematol. 2024 Aug;103(8):3061-3069. doi: 10.1007/s00277-024-05708-w. Epub 2024 May 28.
- Zhang Y, Zhang W, Li J, Duan M, Han B, Zhu T, Zhuang J, Cai H, Cao X, Chen M, Zhou D. Gemcitabine, cisplatin, and dexamethasone (GDP) in combination with methotrexate and pegaspargase is active in newly diagnosed peripheral T cell lymphoma patients: a phase 2, single-center, open-label study in China. Ann Hematol. 2019 Jan;98(1):143-150. doi: 10.1007/s00277-018-3488-1. Epub 2018 Sep 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | 15 mg | — |
| Subject | Tucidinostat | Small molecule | 20 mg | — |
| Subject | Tucidinostat | Small molecule | 25 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 70 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg | Intravenous |
| Background | Prednisone | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Vindesine | Small molecule | 4 mg | Intravenous |