Clinical trial · Interventional
Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma
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
NCT02879526CI-TRIAL-00036387unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapse/Refratory Peripheral T Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-CPT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-CPT
- interventionNames
- Drug: C-CPT
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- One-year
- description
- overall response rate after treated by C-CPT
Secondary outcomes (3)
- measure
- Duration of response
- timeFrame
- One-year
- description
- from the date of response to date of progression, relapse,
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDVose 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
- BACKGROUNDColeman 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
- BACKGROUNDNing 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
- BACKGROUNDShi 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
- BACKGROUNDGong 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
- DERIVEDLiang 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.