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

January 7, 2019 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • HuaiAn, Jiangsu, China, 223300
        • Recruiting
        • Huaian First People's Hospital
        • Contact:
          • Liang Yu, M.D., Ph.D.
      • WuXi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
          • Yun Zhuang, M.D.
        • Contact:
          • YunFeng Shen, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C-CPT
Drug: C-CPT
Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: One-year
overall response rate after treated by C-CPT
One-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response
Time Frame: One-year
from the date of response to date of progression, relapse,
One-year
Progress-free survival
Time Frame: One-year
from date of inclusion to date of progression, relapse, or death from any cause
One-year
Overall survival
Time Frame: One-year
from the date of inclusion to date of death, irrespective of cause
One-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, M.D., Ph.D., The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 21, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPH-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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