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

Study Overview
=================
Brief 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

Official Title
-----------------
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

Conditions
-----------------
Relapse/Refratory Peripheral T Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: C-CPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed Peripheral T Cell Lymphoma,exclude NK/T cell lymphoma Relapse or refractory to at least one prior therapy(chemotherapy or stem cell transplantation) can not age between 18 and 75, both gender ECOG PS 0-1 Peripheral ANC >1.5*109/L; platelet >70*109/L; Hb≥ 90g/L Anticipated survival ≥ 3 months No chemotherapy ,radiotherapy and stem cell transplantation within 4 weeks before inclusion Sign in informed consent form, adherence to the study visit schedule and other protocol requirements Exclusion Criteria: Pregnant women or women in suckling period or with Potentia Generand but not willing to take contraceptives New York Heart Association class III or IV cardiac failure; or history of following disease in past 6 months: acute coronary syndrome, acute heart failure, severe ventricular arrhythmia Poor hepatic function, defined as total bilirubin more than 1.5 fold of upper normal level, ALT, AST more than 2 fold of upper normal level or more than 5fold of upper normal level with hepatic involvement;Poor renal function, defined as serum creatinine more than 1.5 fold of upper normal level CNS or meningeal involvement intervention on myelosuppression within7 days before inclusion patients with active bleeding Major surgery within three weeks before inclusion Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×105 copies/ml; Any psychological conditions which may disturb consent. In any conditions which investigator considered ineligible Known sensitivity or allergy to investigational Product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-CPT<br> | Drug: C-CPT<br>* Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | overall response rate after treated by C-CPT | One-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response | from the date of response to date of progression, relapse, | One-year | 
| Progress-free survival | from date of inclusion to date of progression, relapse, or death from any cause | One-year | 
| Overall survival | from the date of inclusion to date of death, irrespective of cause | One-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapse/Refratory Peripheral T Cell Lymphoma, Chidamide, Cyclophosphamide、Prednisone、Thalidomide(CPT)