Relapse/Refratory Peripheral T Cell LymphomaPhase 2NCT02879526
Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma
A Phase 2 study testing C-CPT in people with Relapse/Refratory Peripheral T Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapse/Refratory Peripheral T Cell Lymphoma
- What is being tested?
- C-CPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2016to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Anticipated survival ≥ 3 months
- No chemotherapy ,radiotherapy and stem cell transplantation within 4 weeks before inclusion
- Sign in informed consent form, adherence to the study visit schedule and other protocol requirements
Who cannot join
- 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
- intervention on myelosuppression within7 days before inclusion
- patients with active bleeding
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- Major surgery within three weeks before inclusion
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
HuaiAn First People's Hospital
HuaiAn, Jiangsu, 223300
Liang Yu, M.D., Ph.D.
- Recruiting
WuXi People's Hospital
Wuxi, Jiangsu, 214023
Yun Zhuang, M.D.
YunFeng Shen, M.D., Ph.D
About this study
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
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
- Being tested
- C-CPT
- Keywords
- Relapse/Refratory Peripheral T Cell Lymphoma, Chidamide, Cyclophosphamide、Prednisone、Thalidomide(CPT)
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CPTDrug
Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd
| Study group | Role | What they receive |
|---|---|---|
| C-CPT | Experimental | Not described Receives: Drug: C-CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
overall response rate after treated by C-CPT
Measured: One-year
Secondary outcomes (3)
Duration of response
from the date of response to date of progression, relapse,
Measured: One-year
Progress-free survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: One-year
Overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relapse/Refratory Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Wei Xu, M.D., Ph.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879526
- Sponsor's protocol ID
- JSPH-003
- Status last verified
- Jan 2019
- First submitted
- 21 Aug 2016
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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 18626005Coleman 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 18338745Ning 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 22080169Shi 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 26105599Gong 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 22339555Liang 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.
PubMed 37839894
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02879526
- Acronym / sponsor ID
- JSPH-003
- Keywords
- Relapse/Refratory Peripheral T Cell Lymphoma, Chidamide, Cyclophosphamide、Prednisone、Thalidomide(CPT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-CPT | Experimental | Drug: C-CPT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- intervention on myelosuppression within7 days before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-CPTChidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd | Drug | C-CPT |
Primary outcome
Overall response rate (ORR)
Time frame: One-year
overall response rate after treated by C-CPT
3 secondary outcomes
Duration of response
Time frame: One-year
Progress-free survival
Time frame: One-year
Overall survival
Time frame: One-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Background: PubMed 18626005Vose 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.
- Background: PubMed 18338745Coleman 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.
- Background: PubMed 22080169Ning 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.
- Background: PubMed 26105599Shi 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.
- Background: PubMed 22339555Gong 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.
- Derived from this study: PubMed 37839894Liang 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xu, M.D., Ph.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C-CPT in people with Relapse/Refratory Peripheral T Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huayuan Zhu, M.D., Ph.D. (86 25 6813 6034, huayuan.zhu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: One-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879526, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.