The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
Study Details
Study Description
Brief Summary
- 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
R-EPOCH
|
Drug: R-EPOCH
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.
Other Names:
|
R-CHOP
|
Drug: R-CHOP
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- progression-free survival [3 years]
Secondary Outcome Measures
- complete response rate [3 years]
- partial response partial response rate [3 years]
- overall response [3 years]
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Public Health Clinical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARL-1