Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)

Study Overview
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Brief Summary
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This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.

Detailed Description
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Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.

Official Title
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Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial

Conditions
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Angioimmunoblastic 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 angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki67. At least on measurable focus (≥1.0*1.0cm by imaging), or at least one evaluable focus; Age 18-75 years, both male and female; ECOG 0-2, KPS≥ 70points; Expected survival ≥3 months; Peripheral blood neutrophil count ≥1.5×10^9/L, platelet count≥ 75×10^9/L, Hb≥ 90g/L; Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum; Negative random pregnancy test for fertile women patients within 7 days before enrollment; No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment; No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range; Exclusion Criteria: Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements; Patients with other malignant tumors simultaneously that have not been effectively controlled; Patients with history of using HDAC inhibitors; Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine; Patients with severe active infection; Patients with HIV or syphilis infection; Patients with prolonged QT interval (male > 450ms，female > 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc); Patients with history of organ transplantation; Patients with history of thrombosis and embolism; Patients with mental disorders or those who are unable to sign a written consent; Patients with drug abuse or long-time alcoholism that may influence the result of the trial; Patients who do not have capacity of legal transactions; Patients currently in other clinical trials; Those who are recognized as inappropriate for the trial by the investigators;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: single arm trial, patients enrolled would be treated in this arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw; | Drug: Chidamide<br>* Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)<br>* Other names: PCT regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate(ORR) | the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission). | every 3 months until 24 months after the last patient's enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of remission | from date of complete remission to date of progression, relapse, or death from any cause | from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment | 
| 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 24 months after the last patient's enrollment | 
| overall survival | from the date of inclusion to date of death, irrespective of cause | 24 months after the last patient's enrollment |