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

NCT ID: NCT03617432

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2022-09-30

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.

Conditions

Experimental Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

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

Doxorubicin

Intervention Type: DRUG

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

Vincristine

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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.

Prednisone

Intervention Type: DRUG

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

Control group

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

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

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

Doxorubicin

Intervention Type: DRUG

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

Vincristine

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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.

Prednisone

Intervention Type: DRUG

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

Interventions

Chidamide

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

Intervention Type: DRUG

Cyclophosphamide

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

Doxorubicin

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

Vincristine

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

Etoposide

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

Prednisone

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

Intervention Type: DRUG

Other Intervention Names

epidaza

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;

3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);

4. Age 18-70 years, male or female;

5. ECOG performance status 0-2;

6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;

7. ALT and serum creatinine <1.5 times of normal maximum;

8. Life expectancy no less than 3 months;

9. Willing to sign the Informed Consent Form.

Exclusion Criteria

1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;

2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;

3. 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;

4. Patients have undergone organ transplantation;

5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;

6. Patients with active hemorrhage;

7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;

8. Patients with active infection or continuous fever within 14 days prior to enrollment;

9. Had major organ surgery within 6 weeks prior to enrollment;

10. 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);

11. Patients with mental disorders or those do not have the ability to consent;

12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;

13. Patients with invasion of central nervous system ;

14. Non-appropriate patients for the trial according to the judgment of the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University International Hospital

OTHER

Sponsor Role: collaborator

Shandong Tumor Hospital

OTHER

Sponsor Role: collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Director of lymphoma department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Zhu, Dr.

Role: CONTACT

dreaming2217@hotmai.com

010-88140650

Yuqin Song, Dr.

Role: CONTACT

songyuqin622@163.com

010-88140650

Facility Contacts

Jun Zhu, MD

Role: primary

zj@bjcancer.org

+86-10-88196596

Weiping Liu, MD

Role: backup

dreaming2217@126.com

+86-10-88196109

Other Identifiers

CSIIT-T13

Identifier Type: -

Identifier Source: org_study_id