Clinical trial NCT02879526: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapse/Refratory Peripheral T Cell Lymphoma
Keywords: Relapse/Refratory Peripheral T Cell Lymphoma
Chidamide
Cyclophosphamide、Prednisone、Thalidomide(CPT)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: One-year
Secondary outcomes:
measure: Duration of response
timeFrame: One-year
measure: Progress-free survival
timeFrame: One-year
measure: Overall survival
timeFrame: One-year
Other outcomes:
Locations:
city: HuaiAn
country: China
facility: HuaiAn First People's Hospital
state: Jiangsu
city: WuXi
country: China
facility: WuXi People's Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wei Xu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.