Relapse/Refratory Peripheral T Cell Lymphoma Clinical Trial
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
| NCT number | NCT02879526 |
| Other study ID # | JSPH-003 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | August 2016 |
| Est. completion date | August 2019 |
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
| Status | Recruiting |
| Enrollment | 45 |
| Est. completion date | August 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | HuaiAn First People's Hospital | HuaiAn | Jiangsu |
| China | WuXi People's Hospital | WuXi | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University |
China,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate (ORR) | overall response rate after treated by C-CPT | One-year | |
| Secondary | Duration of response | from the date of response to date of progression, relapse, | One-year | |
| Secondary | Progress-free survival | from date of inclusion to date of progression, relapse, or death from any cause | One-year | |
| Secondary | Overall survival | from the date of inclusion to date of death, irrespective of cause | One-year |