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

Primary Purpose

Peripheral T Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide plus previous chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

complete response

Secondary Outcome Measures

Progression free survival

Overall survival

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Full Information

NCT ID

NCT02753543

First Posted

April 19, 2016

Last Updated

November 10, 2017

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02753543

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chidamide plus previous chemotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chidamide

Primary Outcome Measure Information:

Title

complete response

Time Frame

21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

1 year

Title

Overall survival

Time Frame

1 year

Title

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）

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Zhao, MD, PhD

Phone

64370045

Ext

610707

zhao.weili@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pengpeng Xu, MD

Phone

64370045

Ext

610707

xpproc@msn.com

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200023

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weili Zhao, MD, PhD

Phone

64370045

Ext

610707

zhao.weili@yahoo.com

First Name & Middle Initial & Last Name & Degree

Pengpeng Xu, MD

Phone

64370045

Ext

610707

xpproc@msn.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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