The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

Study Overview
=================
Brief Summary
-----------------
1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma.

Official Title
-----------------
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

Conditions
-----------------
To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

Intervention / Treatment
-----------------
* Drug: R-EPOCH
* Drug: R-CHOP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged 18-60 years old; Confirmed as AIDS patients and treated with HAART; Confirmed as CD20+ diffuse large B lymphoma; Serum test; negative for HBV, HCV and syphilis; Hematology: Absolute neutrophil count greater than or equal to 1000/mm(3); Platelet count greater than or equal to 50,000/mm(3); Hemoglobin greater than 8.0 g/dl; Lymphocyte count less than or equal to 4,000/mm(3); Chemistry: Serum ALT/AST less or equal to 5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl; Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram; Negative pregnancy test for female; Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment; To be able to understand and sign the Informed Consent Document with legal force. Exclusion Criteria: With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system; Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells; Women with pregnant or breastfeeding; Any form of primary immunodeficiency; Concurrent Systemic steroid therapy; History of severe immediate hypersensitivity reaction to any of the agents used in this study; History of allogeneic stem cell transplantation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| R-EPOCH<br> | Drug: R-EPOCH<br>* Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Etoposide: a topoisomerase inhibitor from the group of epipodofyllotoxins; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.<br>* Other names: Rituximab,Etoposide,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici;|
| R-CHOP<br> | Drug: R-CHOP<br>* Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.<br>* Other names: Rituximab,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate |  | 3 years | 
| partial response partial response rate |  | 3 years | 
| overall response |  | 3 years |