NCT02533700|UnknownPhase 2DMC
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Sponsor study identifier
interventional
106
1 country
4
Study Start
September 2015
Actual (reported)Primary Completion
May 2019
Actual (reported)Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 18, 2015
Actual (reported)August 27, 2015
Actual (reported)September 2015
Actual (reported)May 2019
Actual (reported)December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Percentage of patients with complete remission （CR）
6 months
progression-free survival
2 year since randomization
overall survival
2 year since randomization
overall response rate
6 months
2 cycles of CEOP(cyclophosphamide,vincristine, epirubucin and prednisone),2 cycles of IVE(ifosfamide, epirubucin, etoposide)and 2 cycles of GDP(gemcitabine, cis-platinum, and dexamethasone)
6 cycles of CEOP regimen(cyclophosphamide,vincristin,epirubucin and prednisone)
CEOP: Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 IVE: Ifosfamide 2000mg/m2,ivgtt D1-D3 Epirubucin 70mg/m2, ivgtt D1 Etoposide 100mg/m2, ivgtt D1-D3 GDP: Gemcitabine 1g/m2,ivgtt D1,D8 Cis-platinum 25mg/m2, ivgtt D1-D3 Dexamethasone 40mg, ivgtt D1-D4
CEOP: Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200000, China
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.
Xin Wang, PhD
Shanghai Province Hopsital
106 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2015
First Posted
August 27, 2015
Study Start
September 2015
Actual (reported)adverse events
from randomization to one month after last cycle of treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2019
Actual (reported)Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 10, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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