Tests brentuximab vedotin with chemotherapy for a type of lymphoma
Tests brentuximab vedotin with chemotherapy in adults newly diagnosed with EBV-positive lymphoma.
Plain-language title generated from the registry record
Registry title: Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06925555, who can take part
Where in China
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06925555
- Record updated
- 30 September 2025
- Original description
Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.Read full original descriptionShow less
A Multi-center，Single-arm, Open-label Phase II Clinical Study on Brentuximab Vedotin Combined With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) in the Treatment of Newly Diagnosed EBV-positive Diffuse Large B-cell Lymphoma, Not Otherwise Specified (EBV+ DLBCL-NOS)
Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.
Inclusion: Patients must meet all of the following inclusion criteria to be eligible for enrollment:; BV+DLBCL, NOS diagnosed by pathological diagnosis according to WHO 2016 classification criteria; Sign the informed consent form; Systemic PET/CT performed within 28 days prior to enrollment demonstrating at least one measurable lesion in two perpendicular dimensions (nodal lesion: longest diameter >15 mm, short axis >5 mm; extranodal lesion: longest diameter >10 mm) per Lugano 2014 criteria; ECOG Performance Status (PS) of 0-2; Adequate organ and bone marrow function defined as:; Hematology: Absolute neutrophil count (ANC) ≥1.0×10⁹/L, platelet count (PLT) ≥50×10⁹/L, hemoglobin (HGB) ≥8.0 g/dL; without granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing; Liver function: Total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) ≥50 mL/min; Cardiac function: NYHA class <III; left ventricular ejection fraction (LVEF) ≥50% by echocardiography; Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10 s, prothrombin time (PT) ≤ULN +3 s; Thyroid function: Baseline thyroid-stimulating hormone (TSH) within normal range or abnormal TSH with normal T3/T4 levels and no clinical symptoms; Expected survival ≥ 3 months; Age 18-70 years; For subjects of childbearing potential or with partners of childbearing potential: Agreement to use highly effective contraception during treatment and for 90 days after the last dose.
Exclusion: Patients who meet any of the following criteria will be excluded from the study：; Central nervous system (CNS) involvement; Second primary malignancy (except cured non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma, or breast cancer with no recurrence within 5 years); History of severe allergic diseases, hypersensitivity to macromolecular protein preparations, or any component of Brentuximab Vedotin; Prior allogeneic organ transplant or hematopoietic stem cell transplantation; Concurrent systemic anti-tumor therapy during the study; Anti-cancer vaccines or immunostimulatory anti-tumor therapy within 3 months prior to enrollment; Active severe acute/chronic infection requiring systemic therapy; Active or history of autoimmune disease within 2 years (exceptions: vitiligo, psoriasis, alopecia, Graves' disease without systemic treatment in the past 2 years; hypothyroidism requiring thyroid hormone replacement only; type I diabetes controlled with insulin); Systemic immunosuppressive therapy within 4 weeks prior to enrollment (excluding topical/nasal/inhaled corticosteroids or physiologic doses ≤10 mg/day prednisone equivalent); Positive serology for HIV antibody (HIV-Ab), Treponema pallidum antibody (TP-Ab), HCV antibody (HCV-Ab); HBsAg-positive with HBV DNA >ULN; History of idiopathic pulmonary fibrosis or interstitial pneumonia; Active tuberculosis; Prior ≥Grade 3 immune-related adverse events from immunotherapy; History of neurologic/psychiatric disorders (e.g., epilepsy, dementia); Administration of live vaccines (e.g., influenza, varicella) within 4 weeks prior to treatment or planned during the study; History of alcohol/drug abuse; Pregnancy or lactation; Participation in another interventional clinical trial within 1 month prior to enrollment; Other factors deemed by investigators to potentially compromise efficacy/safety assessments.