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Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

Primary Purpose

Experimental Tumor

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide

Cyclophosphamide

Doxorubicin

Vincristine

Etoposide

Prednisone

About this trial

This is an interventional treatment trial for Experimental Tumor

Eligibility Criteria

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

Inclusion Criteria:

Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
Age 18-70 years, male or female;
ECOG performance status 0-2;
Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
ALT and serum creatinine <1.5 times of normal maximum;
Life expectancy no less than 3 months;
Willing to sign the Informed Consent Form.

Exclusion Criteria:

NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
Patients have undergone organ transplantation;
Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
Patients with active hemorrhage;
Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
Patients with active infection or continuous fever within 14 days prior to enrollment;
Had major organ surgery within 6 weeks prior to enrollment;
Impaired liver function ( Total bilirubin > 1.5 times of normal maximum, ALT/AST> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST> 5 times of normal maximum), impaired renal function (serum creatinine> 1.5 times of normal maximum);
Patients with mental disorders or those do not have the ability to consent;
Patients with drug abuse, long term alcoholism that may impact the results of the trial;
Patients with invasion of central nervous system ;
Non-appropriate patients for the trial according to the judgment of the investigators.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental group

Control group

Arm Description

Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

Outcomes

Primary Outcome Measures

complete remission (CR）rate

The rate of patients who achieve complete remission after the treatment.

Secondary Outcome Measures

objective response rate（ORR）

The total proportion of patients with complete response（CR）and partial response（PR）.

progression-free survival（PFS）

Time from treatment until disease progression or death.

overall survival（OS）

From the date of inclusion to date of death, irrespective of any cause.

Full Information

NCT ID

NCT03617432

First Posted

August 1, 2018

Last Updated

August 30, 2018

Sponsor

Peking University

Collaborators

Peking University International Hospital, Shandong Tumor Hospital, Jiangxi Provincial Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03617432

Brief Title

Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

Official Title

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 28, 2018 (Actual)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

Collaborators

Peking University International Hospital, Shandong Tumor Hospital, Jiangxi Provincial Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Detailed Description

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.

6. Conditions and Keywords

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

Experimental Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

Arm Title

Control group

Arm Type

Experimental

Arm Description

Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Chidamide

Other Intervention Name(s)

epidaza

Intervention Description

Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.

Primary Outcome Measure Information:

Title

complete remission (CR）rate

Description

The rate of patients who achieve complete remission after the treatment.

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

objective response rate（ORR）

Description

The total proportion of patients with complete response（CR）and partial response（PR）.

Time Frame

up to 2 years

Title

progression-free survival（PFS）

Description

Time from treatment until disease progression or death.

Time Frame

2 years

Title

overall survival（OS）

Description

From the date of inclusion to date of death, irrespective of any cause.

Time Frame

2 years after the 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

Eligibility Criteria

Inclusion Criteria: Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled; Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD; Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci); Age 18-70 years, male or female; ECOG performance status 0-2; Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L; ALT and serum creatinine <1.5 times of normal maximum; Life expectancy no less than 3 months; Willing to sign the Informed Consent Form. Exclusion Criteria: NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma; Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures; QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment; Patients have undergone organ transplantation; Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment; Patients with active hemorrhage; Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction; Patients with active infection or continuous fever within 14 days prior to enrollment; Had major organ surgery within 6 weeks prior to enrollment; Impaired liver function ( Total bilirubin > 1.5 times of normal maximum, ALT/AST> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST> 5 times of normal maximum), impaired renal function (serum creatinine> 1.5 times of normal maximum); Patients with mental disorders or those do not have the ability to consent; Patients with drug abuse, long term alcoholism that may impact the results of the trial; Patients with invasion of central nervous system ; Non-appropriate patients for the trial according to the judgment of the investigators.

Central Contact Person:

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

Jun Zhu, Dr.

Phone

010-88140650

dreaming2217@hotmai.com

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

Yuqin Song, Dr.

Phone

010-88140650

songyuqin622@163.com

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

Phone

+86-10-88196596

zj@bjcancer.org

First Name & Middle Initial & Last Name & Degree

Weiping Liu, MD

Phone

+86-10-88196109

dreaming2217@126.com

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

12. IPD Sharing Statement

Plan to Share IPD

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Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

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