NCT02879526

Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma

Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II, Single-arm, Open-label, Muti-center Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate efficacy and safety of Chidamide Combined With Cyclophosphamide,Prednisone,Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center Study

Detailed description

Chidamide is a new histone deacetylase inhibitor and shows anti-tumor activity in Relapse/Refratory Peripheral T Cell Lymphoma.Cyclophosphamide,Prednisone,Thalidomide(CPT) is an oral combination regimen for lymphoma patients who can not stand the standard chemotherapy. The investigators therefore design this open-label,phase II, single-arm trial to investigate the efficacy of Chidamide Combined With CPT in treatment of fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma Primary Outcome Measures: • overall response rate Secondary Outcome Measures: * duration of response * progression free survival * overall survival Enrollment:45 Study Start Date: August 2016 Primary Completion Date: March 2018

Conditions

• Relapse/Refratory Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	C-CPT	Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-06-01
• Completion: 2019-08-01
• First posted: 2016-08-25
• Last updated: 2019-01-08

Locations

2 sites across 1 country: China