Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.

Official Title
-----------------
Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study

Conditions
-----------------
Lymphoma, Large B-Cell, Diffuse

Intervention / Treatment
-----------------
* Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved CD20+ DLBCL; relapse or refractory DLBCL# previously received systemic chemotherapy with anthracycline# not eligible for autologous hematopoietic stem cell transplantation# at least one evaluable lesion# ECOG PS 0-1; 18-75 years; without other malignancy; proper functioning of the major organs. Exclusion Criteria: double-hit lymphoma; previously received treatment of HDAC inhibitor; plan to receive autologous stem cell transplantation; involvement of central nervous system; previously received gemcitabine within the past 6 months; patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Chidamide combined with R-GemOx<br>Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy. | Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin<br>* All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy. Patients with CR or PR will receive chidamide maintenance therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma. | 4-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOR | the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier. | 4-years | 
| PFS | the time from the date of enrollment until either PD or death. | 4-years | 
| OS | the time from the date of enrollment until death | 4-years |