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

Experimental Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617432
• Other study ID #: CSIIT-T13
• Status: Recruiting
• Phase: Phase 2
• Start date: August 28, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2018
• Source: Peking University
• Contact: Jun Zhu, Dr.
• Phone: 010-88140650
• Email: dreaming2217[@]hotmai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Experimental Tumor
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

Intervention

Drug:
• Chidamide
Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
• Cyclophosphamide
Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
• Doxorubicin
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
• Vincristine
Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University	Jiangxi Provincial Cancer Hospital, Peking University International Hospital, Shandong Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission (CR)rate	The rate of patients who achieve complete remission after the treatment.	up to 2 years
Secondary	objective response rate(ORR)	The total proportion of patients with complete response(CR)and partial response(PR).	up to 2 years
Secondary	progression-free survival(PFS)	Time from treatment until disease progression or death.	2 years
Secondary	overall survival(OS)	From the date of inclusion to date of death, irrespective of any cause.	2 years after the last patient's enrollment.