Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.

Detailed Description
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After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.

Official Title
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Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients

Conditions
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Peripheral T Cell Lymphoma

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）; De novo peripheral T cell lymphoma patients; Age 18-70 years old; ECOG≤2； Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter; The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci); Willing to sign a written consent. Exclusion Criteria: T lymphoblast lymphoma; Bone marrow infiltrated with lymphoma cell ≥25%； NT/T cell lymphoma; Granuloma fungoides; Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum); Uncontrolled infection; Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2); With other tumors; With other condition that cause the patient unable to sign the written consent;

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone. | Drug: Chidamide<br>* Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.<br>* Other names: CHOP regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission Rate | the rate of patients who achieve complete remission after the treatment | every 3 months until 30 months after the last patient's enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment | 
| duration of remission | from date of complete remission to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment | 
| overall survival | from the date of inclusion to date of death, irrespective of cause | 30 months after the last patient's enrollment | 
| adverse events | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure | from the date of first cycle of treatment to 30 months after last patient's enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chidamide, CHOP regimen