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

Phase 2

• Conditions: Relapse/Refratory Peripheral T Cell Lymphoma
• Interventions: Drug: C-CPT

• Registration Number: NCT02879526
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-21
• Study First Submitted QC: 2016-08-21
• Study First Posted: 2016-08-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08
• Primary Completion: 2019-06
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Histologically confirmed Peripheral T Cell Lymphoma,exclude NK/T cell lymphoma
2. Relapse or refractory to at least one prior therapy(chemotherapy or stem cell transplantation)
3. can not
4. age between 18 and 75, both gender
5. ECOG PS 0-1
6. Peripheral ANC >1.5*109/L; platelet >70*109/L; Hb≥ 90g/L
7. Anticipated survival ≥ 3 months
8. No chemotherapy ,radiotherapy and stem cell transplantation within 4 weeks before inclusion
9. Sign in informed consent form, adherence to the study visit schedule and other protocol requirements

Exclusion Criteria

1. Pregnant women or women in suckling period or with Potentia Generand but not willing to take contraceptives
2. 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
3. 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
4. CNS or meningeal involvement
5. intervention on myelosuppression within7 days before inclusion
6. patients with active bleeding
7. Major surgery within three weeks before inclusion
8. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×105 copies/ml;
9. Any psychological conditions which may disturb consent.
10. In any conditions which investigator considered ineligible
11. Known sensitivity or allergy to investigational Product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-CPT	C-CPT	-

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	One-year	overall response rate after treated by C-CPT

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

HuaiAn First People's Hospital; 🇨🇳 HuaiAn, Jiangsu, China

WuXi People's Hospital; 🇨🇳 WuXi, Jiangsu, China