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

Peking University

Status and phase

Unknown

Phase 2

Conditions

Experimental Tumor

Treatments

Drug: Cyclophosphamide

Drug: Prednisone

Drug: Doxorubicin

Drug: Etoposide

Drug: Chidamide

Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT03617432

CSIIT-T13

Details and patient eligibility

About

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

Full 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.

Enrollment

114 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

Experimental group

Description:

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

Treatment: