Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.

Detailed Description
-----------------
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.

Official Title
-----------------
Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study

Conditions
-----------------
Angioimmunoblastic T-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Azacitidine
* Drug: Chidamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification; Age≥18years; ECOG≤2; Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment; Adequate bone marrow hematopoietic function: ANC>1.5 × 109/L，HGB>90g/L，PLT>80 × 109/L; Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA); Exclusion Criteria: Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; Pregnant or lactating women;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azacytidine combined with chidamide<br>Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days. | Drug: Azacitidine<br>* 75 mg/m2 subcutaneously on days 1-7<br>Drug: Chidamide<br>* 20mg orally per week continuously<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR was defined as the proportion of patients who achieved CR or PR as their best response | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) | PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up. | 1 year | 
| Duration of response (DOR) | DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse. | through study completion, an average of 1 year | 
| overall survival (OS) | OS was defined as time from diagnosis to death from any cause or the last follow-up. | through study completion, an average of 2 year | 
| Adverse Events | Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | During the whole treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angioimmunoblastic T-cell Lymphoma, Azacytidine, Chidamide