HIV-Related Diffuse Large B-Cell Lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Age >= 18 years; 2. Provision of signed Informed Consent Form (ICF); 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) by tissue biopsy according to the World Health Organization (WHO) classification (including DLBCL, not otherwise specified [NOS], or unclassifiable DLBCL); 4. No prior treatment for lymphoma (except for glucocorticoids); 5. Positive for human immunodeficiency virus (HIV) antibody; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. History of severe cardiac disease: New York Heart Association (NYHA) Class III or IV, congestive heart failure, myocardial infarction , cerebrovascular accident, unstable arrhythmia, unstable angina, or a history of multiple cardiovascular events within the past 3 months, or severe pulmonary disease. 2. Central nervous system (CNS) involvement by lymphoma. 3. Uncontrolled severe infection within 4 weeks prior to study enrollment, including bacterial, viral, fungal, mycobacterial, or other pathogen infections, or active tuberculosis. 4. Presence of an active malignancy that, in the investigator's judgment, may interfere with study results or affect survival, with the exception of non-melanoma skin cancer or stage 0 (in situ) cervical cancer, malignancies treated with curative intent and with no evidence of recurrence for > 2 years, or low-grade prostate cancer not requiring treatment. 5. Known hypersensitivity to Chinese hamster ovary (CHO) cell products, or any components of rituximab, polatuzumab vedotin, and/or the contrast media used in the study. 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-assessed Complete Response Rate (CRR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free Survival Rate;Overall Survival;Disease-Free Survival;Duration of Response; | — |
Countries
China
Contacts
Chongqing University Cancer Hospital