CClinicalTrials.gg
Sign In
Status unknownNCT02879526Updated Jan 8, 2019

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

A Phase 2 interventional study of C-CPT in Relapse/Refratory Peripheral T Cell Lymphoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Relapse/Refratory Peripheral T Cell Lymphoma

Keywords

  • Relapse/Refratory Peripheral T Cell Lymphoma
  • Chidamide
  • Cyclophosphamide、Prednisone、Thalidomide(CPT)
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 45 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    C-CPT

    Drug: C-CPT

Interventions

  • DrugC-CPT

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

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

    overall response rate after treated by C-CPT

    Time frame: One-year

Secondary outcomes

  1. Duration of response

    from the date of response to date of progression, relapse,

    Time frame: One-year

  2. Progress-free survival

    from date of inclusion to date of progression, relapse, or death from any cause

    Time frame: One-year

  3. Overall survival

    from the date of inclusion to date of death, irrespective of cause

    Time frame: One-year

07

Study locations

2 of 2 sites recruiting
  • HuaiAn First People's Hospital
    HuaiAn, Jiangsu 223300, China
    • Liang Yu, M.D., Ph.D. · Contact
    Recruiting
  • WuXi People's Hospital
    WuXi, Jiangsu 214023, China
    • Yun Zhuang, M.D. · Contact
    • YunFeng Shen, M.D., Ph.D · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 18626005 ↗
  • 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. PubMed 18338745 ↗
  • 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. PubMed 22080169 ↗
  • 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. PubMed 26105599 ↗
  • 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. PubMed 22339555 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02879526
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
WEI XU (Professor, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Aug 25, 2016
Start date
Aug 2016
Primary completion
Jun 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Jan 8, 2019

Study contacts

Huayuan Zhu, M.D., Ph.D.
Contact
huayuan.zhu@hotmail.com
86 25 6813 6034
Wei Xu, M.D., Ph.D.
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma→

Other studies from this sponsor

The First Affiliated Hospital with Nanjing Medical University

Start the discussion