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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02879526

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

22.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Relapse/Refratory Peripheral T Cell Lymphoma	Drug: C-CPT	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C-CPT	Drug: C-CPT Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd

Arm

Intervention/Treatment

Experimental: C-CPT

Drug: C-CPT

Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd

Outcome Measures

Primary Outcome Measures

Overall response rate (ORR) [One-year]
overall response rate after treated by C-CPT

Secondary Outcome Measures

Duration of response [One-year]
from the date of response to date of progression, relapse,
Progress-free survival [One-year]
from date of inclusion to date of progression, relapse, or death from any cause
Overall survival [One-year]
from the date of inclusion to date of death, irrespective of cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >1.5109/L; platelet >70109/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.