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

Shanghai Public Health Clinical Center

Status: Unknown

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

Treatments: Drug: R-EPOCH; Drug: R-CHOP

Study type: Observational

Funder types: Other

Identifiers

NCT03045471

ARL-1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. male or female aged 18-60 years old;
2. Confirmed as AIDS patients and treated with HAART;
3. Confirmed as CD20+ diffuse large B lymphoma;
4. Serum test; negative for HBV, HCV and syphilis;
5. 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);
6. 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;
7. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram;
8. Negative pregnancy test for female;
9. 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;
10. To be able to understand and sign the Informed Consent Document with legal force.

Exclusion criteria

1. With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;
2. Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;
3. Women with pregnant or breastfeeding;
4. Any form of primary immunodeficiency;
5. Concurrent Systemic steroid therapy;
6. History of severe immediate hypersensitivity reaction to any of the agents used in this study;
7. History of allogeneic stem cell transplantation.

Trial design

50 participants in 2 patient groups

R-EPOCH

Treatment:

Drug: R-EPOCH

R-CHOP

Treatment:

Drug: R-CHOP