Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma
Primary Purpose
Relapse/Refratory Peripheral T Cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
C-CPT
Sponsored by
About this trial
This is an interventional treatment trial for Relapse/Refratory Peripheral T Cell Lymphoma focused on measuring Relapse/Refratory Peripheral T Cell Lymphoma, Chidamide, Cyclophosphamide、Prednisone、Thalidomide(CPT)
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.
Sites / Locations
- HuaiAn First People's HospitalRecruiting
- WuXi People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-CPT
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate (ORR)
overall response rate after treated by C-CPT
Secondary Outcome Measures
Duration of response
from the date of response to date of progression, relapse,
Progress-free survival
from date of inclusion to date of progression, relapse, or death from any cause
Overall survival
from the date of inclusion to date of death, irrespective of cause
Full Information
NCT ID
NCT02879526
First Posted
August 21, 2016
Last Updated
January 7, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02879526
Brief Title
Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse/Refratory Peripheral T Cell Lymphoma
Keywords
Relapse/Refratory Peripheral T Cell Lymphoma, Chidamide, Cyclophosphamide、Prednisone、Thalidomide(CPT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-CPT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
C-CPT
Intervention Description
Chidamide 30mg ,twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
overall response rate after treated by C-CPT
Time Frame
One-year
Secondary Outcome Measure Information:
Title
Duration of response
Description
from the date of response to date of progression, relapse,
Time Frame
One-year
Title
Progress-free survival
Description
from date of inclusion to date of progression, relapse, or death from any cause
Time Frame
One-year
Title
Overall survival
Description
from the date of inclusion to date of death, irrespective of cause
Time Frame
One-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huayuan Zhu, M.D., Ph.D.
Phone
86 25 6813 6034
Email
huayuan.zhu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xu, M.D., Ph.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HuaiAn First People's Hospital
City
HuaiAn
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Yu, M.D., Ph.D.
Facility Name
WuXi People's Hospital
City
WuXi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Zhuang, M.D.
First Name & Middle Initial & Last Name & Degree
YunFeng Shen, M.D., Ph.D
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
18626005
Citation
Vose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14.
Results Reference
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PubMed Identifier
18338745
Citation
Coleman M, Martin P, Ruan J, Furman R, Niesvizky R, Elstrom R, George P, Kaufman TP, Leonard JP. Prednisone, etoposide, procarbazine, and cyclophosphamide (PEP-C) oral combination chemotherapy regimen for recurring/refractory lymphoma: low-dose metronomic, multidrug therapy. Cancer. 2008 May 15;112(10):2228-32. doi: 10.1002/cncr.23422.
Results Reference
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PubMed Identifier
22080169
Citation
Ning ZQ, Li ZB, Newman MJ, Shan S, Wang XH, Pan DS, Zhang J, Dong M, Du X, Lu XP. Chidamide (CS055/HBI-8000): a new histone deacetylase inhibitor of the benzamide class with antitumor activity and the ability to enhance immune cell-mediated tumor cell cytotoxicity. Cancer Chemother Pharmacol. 2012 Apr;69(4):901-9. doi: 10.1007/s00280-011-1766-x. Epub 2011 Nov 12.
Results Reference
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PubMed Identifier
26105599
Citation
Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23.
Results Reference
background
PubMed Identifier
22339555
Citation
Gong K, Xie J, Yi H, Li W. CS055 (Chidamide/HBI-8000), a novel histone deacetylase inhibitor, induces G1 arrest, ROS-dependent apoptosis and differentiation in human leukaemia cells. Biochem J. 2012 May 1;443(3):735-46. doi: 10.1042/BJ20111685.
Results Reference
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Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma
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