Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma

November 10, 2017 updated by: Zhao Weili, Ruijin Hospital

A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma

This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

33

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
    • Shanghai
      • Shanghai, Shanghai, China, 200023
        • Recruiting
        • Ruijin Hospital
        • Contact:
        • Contact:

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

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
  • Age ≧16 years, ≦75 years
  • ECOG (Eastern Cooperative Oncology Group) =0,1,2
  • No previous history of malignancy
  • Radiologically measurable disease
  • Life expectancy>6 months
  • Informed consented

Exclusion Criteria:

  • Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy

  • Lab at enrollment(unless caused by lymphoma)

    • Neutrophile<1.5*10^9/L
    • Platelet<75*10^9/L
    • Hemoglobulin<90g/L
    • ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal )
    • Creatinine>1.5*ULN

  • Other uncontrollable medical condition that may that may interfere the participation of the study

    • Not able to comply to the protocol for mental or other unknown reasons
  • Pregnant or lactation
  • HIV infection

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: Chidamide plus previous chemotherapy
Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles
Drug: Chidamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete response
Time Frame: 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Progression free survival
Time Frame: 1 year
1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）
Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

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

November 1, 2015

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ-PTCL-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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