CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

Phase 2 Unknown 106 enrolled Shandong Provincial Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.

Timeline

Start: 2015-09
Primary completion: 2019-05
Completion: 2020-12

Outcome

Missed primary endpoint

paper a complete response rate of the CEOP/IVE/GDP group was similar to that of the CEOP group (37.3% vs. 31.4%, p = 0.532). PMID 32349779 ↗

Publications

Cai MC, Cheng S, Wang X, Hu JD, Song YP, Huang YH, Yan ZX, Jiang YJ, Fang XS, Zheng XY, Dong LH, Ji MM, Wang L, Xu PP, Zhao WL. CEOP/IVE/GDP alternating regimen compared with CEOP as the first-line therapy for newly diagnosed patients with peripheral T cell lymphoma: results from a phase 2, multicenter, randomized, controlled clinical trial. Genome Med. 2020 Apr 30;12(1):41. doi: 10.1186/s13073-020-00739-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	40 mg	Intravenous
Subject	Epirubucin	Unknown	70 mg/m2	Intravenous
Subject	Etoposide	Small molecule	100 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1 g	Intravenous
Subject	Ifosfamide	Small molecule	2000 mg/m2	Intravenous
Subject	Prednisone	Other / unclassified	60 mg/m2	Oral
Subject	Vincristine	Small molecule	1.4 mg/m2	Intravenous