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

NCT02879526 | Unknown Phase 2 DMC

• 1 other identifier: JSPH-003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

Relapse/Refratory Peripheral T Cell Lymphoma

Keywords

Relapse/Refratory Peripheral T Cell Lymphoma; Chidamide; Cyclophosphamide、Prednisone、Thalidomide(CPT)

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  overall response rate after treated by C-CPT

  One-year

Secondary Outcomes (3)

• Duration of response

  One-year

• Progress-free survival

  One-year

• Overall survival

  One-year

Study Arms (1)

C-CPT

EXPERIMENTAL

Drug: C-CPT

Interventions

C-CPT DRUG

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

C-CPT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Sign in informed consent form, adherence to the study visit schedule and other protocol requirements

You may not qualify if:

• 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
• patients with active bleeding
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (2)

HuaiAn First People's Hospital

HuaiAn, Jiangsu, 223300, China

RECRUITING

WuXi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 18626005 BACKGROUND

• 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.

  PMID: 18338745 BACKGROUND

• 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.

  PMID: 22080169 BACKGROUND

• 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.

  PMID: 26105599 BACKGROUND

• 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.

  PMID: 22339555 BACKGROUND

• Liang J, Wang L, Wang X, Cui G, Zhou J, Xing T, Du K, Xu J, Wang L, Liang R, Chen B, Cheng J, Shen H, Li J, Xu W. Chidamide plus prednisone, cyclophosphamide, and thalidomide for relapsed or refractory peripheral T-cell lymphoma: A multicenter phase II trial. Chin Med J (Engl). 2024 Jul 5;137(13):1576-1582. doi: 10.1097/CM9.0000000000002836. Epub 2023 Dec 10.

  PMID: 37839894 DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Xu, M.D., Ph.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huayuan Zhu, M.D., Ph.D.

CONTACT

86 25 6813 6034; huayuan.zhu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: August 25, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)