NCT03617432

Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Detailed description

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.

Conditions

• Experimental Tumor

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUG	Cyclophosphamide	Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUG	Doxorubicin	Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUG	Vincristine	Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUG	Etoposide	Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUG	Prednisone	Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Timeline

• Start date: 2018-08-28
• Primary completion: 2020-09-30
• Completion: 2022-09-30
• First posted: 2018-08-06
• Last updated: 2018-09-04

Locations

1 site across 1 country: China