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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Experimental Tumor

Intervention / Treatment
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* Drug: Chidamide
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Etoposide
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. | Drug: Chidamide<br>* Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>* Other names: epidaza;Drug: Cyclophosphamide<br>* Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>Drug: Doxorubicin<br>* Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>Drug: Vincristine<br>* Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>Drug: Etoposide<br>* 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.<br>Drug: Prednisone<br>* Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>|
| Experimental: Control group<br>Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. | Drug: Cyclophosphamide<br>* Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>Drug: Doxorubicin<br>* Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>Drug: Vincristine<br>* Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>Drug: Etoposide<br>* 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.<br>Drug: Prednisone<br>* Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission (CR）rate | The rate of patients who achieve complete remission after the treatment. | up to 2 years | 

Secondary Outcome Measures

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