Chidamide Plus R-CHOP in Elderly DLBCL

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.

Official Title
-----------------
A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisone
* Drug: Chidamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive Age 61-75 years ECOG 0,1,2 Life expectancy>6 months Informed consented IPI>1 Exclusion Criteria: Chemotherapy before Stem cell transplantation before History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Primary CNS lymphoma LVEF≤50% Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Ages Eligible for Study
-----------------
Minimum Age: 61 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 plus R-CHOP<br>Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles | Drug: Rituximab<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Doxorubicin<br> <br> Drug: Vincristine<br> <br> Drug: Prednisone<br> <br> Drug: Chidamide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 21 days after 6 cycles of treatment (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival rate |  | 2 year | 
| Overall survival rate |  | 2 year | 
| Overall response rate |  | 21 days after 6 cycles of treatment (each cycle is 21 days) | 
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |  | Each cycle of treatment and then every 3 months for 2 years |