The efficacy and safety of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-16010056

Enrollment

Unknown

Registered

2016-11-30

Start date

2016-12-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS-associated CD20+ diffuse large B lymphoma

Interventions

R-EPOCH regimen group:R-EPOCH regimen treatment

R-CHOP regimen group:R-CHOP regimen treatment

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
progression-free survival;	—

Secondary

Measure	Time frame
complete response;partial response;overall response;stable disease;progressive disease;	—

Countries

China

Contacts

Public ContactRenfang Zhang

Shanghai Public Health Clinical Center

zhangrenfang@shaphc.org+86 18916051096

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026