HIV-associated lymphoma
Conditions
Interventions
Experimental group:PD-1+HAART+R-SC-EPOCH
Control group:R-EPOCH
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients diagnosed with DLBCL based on histopathological or cytological examination and HIV positive with CD4>100x10^9/L; 2. Aged 18-70 years, no gender limit; 3. Informed consent has been signed before conducting any specific research operation; 4. Have at least one measurable lesion. For intranodal lesions, it was defined as: long diameter >=1.5cm and short diameter >=1.0cm; For extranodal lesions, length diameter >=1.0cm; 5. The physical status score of the Eastern Oncology Consortium (ECOG) was 0-2; 6. Left ventricular ejection fraction (LVEF) was >=50% by echocardiography; 7. Absolute neutrophil count >=1.5x10^9/L; Hemoglobin >=75g/L, platelet count >=75x10^9/L; 8. Total bilirubin level <=1.5x upper limit of normal value (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=2.5xULN; 9. Serum creatinine level <=1.5xULN; 10. Prothrombin time (PT) or activated partial thrombin time (APTT) or International Standardized Ratio (INR) <=1.5xULN in the absence of anticoagulant therapy; 11. HIV viral load < 40 copies /ml; 12. For patients of reproductive age who have not been sterilized, consent is required to use effective contraception during treatment and for 12 months after the last administration of the study drug; 13. In the researchers' judgment, the expected survival time was at least six months.
Exclusion criteria
Exclusion criteria: 1. Participated in other interventional clinical trials within 3 months before enrollment. Patients participating in the non-interventional trial were eligible to participate in this study; 2. Clinically significant heart disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure (NYHA) grade III or IV cardiac function; 3. A history of severe neurological or mental illness, including dementia or epilepsy; 4. Patients with hypothyroidism; 5. Patients who were scheduled to undergo major surgery within 28 days before enrollment, or whose surgical wounds were not healed; 6. Ongoing corticosteroid treatment with dose > 30mg/ day prednisone or equivalent dose of corticosteroid for >=10 days; 7. History of gastrointestinal perforation and/or fistula within 6 months prior to enrollment; 8. Known allergy to monoclonal antibody (mAb) therapy or rituximab; 9. Patients who have a taboo against any component of PD-1 or EPOCH; 10. Previous DLBCL-specific therapy, including chemotherapy, immunotherapy, local radiotherapy for lymphoma, and any monoclonal antibody therapy within 3 months prior to enrollment; 11. Previous treatment with cytotoxic drugs or anti-CD20 mab for other diseases (such as rheumatoid arthritis); 12. Primary central nervous system lymphoma and secondary central nervous system invasion; Patients with primary testicular lymphoma; 13. Patients with a combined history of other malignancies that might affect protocol compliance or outcome analysis, including a history of cured basal cell or squamous cell carcinoma of the skin, or cutaneous melanoma or cervical carcinoma in situ, could be enrolled; 14. Any known uncontrolled active infectious disease or major infection event requiring hospitalization (other than neoplastic fever) during the 4 weeks prior to enrollment; 15. For acute or chronic hepatitis B virus infection, if either or both hepatitis B virus (HBV) surface antigens and HBV core antibodies are positive, only HBV DNA below the minimum detection limit can be enrolled; 16. Those who were not considered suitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactHuang Dehong
Chongqing University Cancer Hospital
Outcome results
None listed