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

Primary Purpose

Peripheral T Cell Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma focused on measuring Chidamide, CHOP regimen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • the First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.

Outcomes

Primary Outcome Measures

Complete Remission Rate
the rate of patients who achieve complete remission after the treatment

Secondary Outcome Measures

progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
duration of remission
from date of complete remission to date of progression, relapse, or death from any cause
overall survival
from the date of inclusion to date of death, irrespective of cause
adverse events
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

Full Information

First Posted
August 30, 2017
Last Updated
August 30, 2017
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT03268889
Brief Title
Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)
Acronym
CHOP
Official Title
Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
September 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma
Keywords
Chidamide, CHOP regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
CHOP regimen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Remission Rate
Description
the rate of patients who achieve complete remission after the treatment
Time Frame
every 3 months until 30 months after the last patient's enrollment
Secondary Outcome Measure Information:
Title
progression free survival
Description
from date of inclusion to date of progression, relapse, or death from any cause
Time Frame
from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
Title
duration of remission
Description
from date of complete remission to date of progression, relapse, or death from any cause
Time Frame
from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
Title
overall survival
Description
from the date of inclusion to date of death, irrespective of cause
Time Frame
30 months after the last patient's enrollment
Title
adverse events
Description
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
Time Frame
from the date of first cycle of treatment to 30 months after last patient's enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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）; De novo peripheral T cell lymphoma patients; Age 18-70 years old; ECOG≤2； 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; The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci); Willing to sign a written consent. Exclusion Criteria: T lymphoblast lymphoma; Bone marrow infiltrated with lymphoma cell ≥25%； NT/T cell lymphoma; Granuloma fungoides; Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum); Uncontrolled infection; Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2); With other tumors; With other condition that cause the patient unable to sign the written consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengming Jin, MD,PhD
Phone
（+86）512-65223637
Email
suzhouhematology@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengming Jin, MD,PhD
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengming Jin, MD, PhD
Phone
(+86)512-67781856

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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