Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma) (CHOP)

August 30, 2017 updated by: The First Affiliated Hospital of Soochow University

Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients

This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Zhengming Jin, MD, PhD
          • Phone Number: (+86)512-67781856

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）;
  2. De novo peripheral T cell lymphoma patients;
  3. Age 18-70 years old;
  4. ECOG≤2；
  5. Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
  6. The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
  7. Willing to sign a written consent.

Exclusion Criteria:

  1. T lymphoblast lymphoma;
  2. Bone marrow infiltrated with lymphoma cell ≥25%；
  3. NT/T cell lymphoma;
  4. Granuloma fungoides;
  5. Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);
  6. Uncontrolled infection;
  7. Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
  8. With other tumors;
  9. With other condition that cause the patient unable to sign the written consent;

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: treatment group
In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.
Drug: Chidamide
Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
Other Names:
  • CHOP regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission Rate
Time Frame: every 3 months until 30 months after the last patient's enrollment
the rate of patients who achieve complete remission after the treatment
every 3 months until 30 months after the last patient's enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
from date of inclusion to date of progression, relapse, or death from any cause
from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
overall survival
Time Frame: 30 months after the last patient's enrollment
from the date of inclusion to date of death, irrespective of cause
30 months after the last patient's enrollment
adverse events
Time Frame: from the date of first cycle of treatment to 30 months after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
from the date of first cycle of treatment to 30 months after last patient's enrollment
duration of remission
Time Frame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
from date of complete remission to date of progression, relapse, or death from any cause
from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Zhengming Jin, MD,PhD, The First Affiliated Hospital of Soochow University

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 (ACTUAL)

June 15, 2017

Primary Completion (ANTICIPATED)

June 15, 2020

Study Completion (ANTICIPATED)

September 15, 2020

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (ACTUAL)

August 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jinzm 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the data would be available at the First Affiliated Hospital after the study is finished

IPD Sharing Time Frame

From the time of study finish

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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