Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients diagnosed with a specific type of lymphoma called EBV-Positive Diffuse Large B-Cell Lymphoma (DLBCL). The treatment involves combining a medication called Brentuximab Vedotin with standard chemotherapy (R-CHP). The goal is to evaluate how safe and effective this combination is for patients who are newly diagnosed with this condition.

To participate in the trial, individuals must be between 18 and 70 years old and have a confirmed diagnosis of EBV-positive DLBCL. They should show signs of the disease through imaging tests, have a good performance status (meaning they are generally healthy enough to participate), and meet certain health criteria regarding blood counts and organ function. Participants can expect regular monitoring throughout the study and will need to agree to use effective birth control if they are of childbearing age. This trial is not yet recruiting, so interested individuals will need to wait until it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• - Patients must meet all of the following inclusion criteria to be eligible for enrollment:
• • 1. BV+DLBCL, NOS diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
• • 2. Sign the informed consent form;
• • 3. 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;
• • 4. ECOG Performance Status (PS) of 0-2;
• 5. 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.
• • 6. Expected survival ≥ 3 months.
• • 7. Age 18-70 years.
• • 8. 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 Criteria:
• • Patients who meet any of the following criteria will be excluded from the study：
• • 1. Central nervous system (CNS) involvement.
• • 2. 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).
• • 3. History of severe allergic diseases, hypersensitivity to macromolecular protein preparations, or any component of Brentuximab Vedotin.
• • 4. Prior allogeneic organ transplant or hematopoietic stem cell transplantation.
• • 5. Concurrent systemic anti-tumor therapy during the study.
• • 6. Anti-cancer vaccines or immunostimulatory anti-tumor therapy within 3 months prior to enrollment.
• • 7. Active severe acute/chronic infection requiring systemic therapy.
• • 8. 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).
• • 9. Systemic immunosuppressive therapy within 4 weeks prior to enrollment (excluding topical/nasal/inhaled corticosteroids or physiologic doses ≤10 mg/day prednisone equivalent).
• • 10. Positive serology for HIV antibody (HIV-Ab), Treponema pallidum antibody (TP-Ab), HCV antibody (HCV-Ab); HBsAg-positive with HBV DNA \>ULN.
• • 11. History of idiopathic pulmonary fibrosis or interstitial pneumonia.
• • 12. Active tuberculosis.
• • 13. Prior ≥Grade 3 immune-related adverse events from immunotherapy.
• • 14. History of neurologic/psychiatric disorders (e.g., epilepsy, dementia).
• • 15. Administration of live vaccines (e.g., influenza, varicella) within 4 weeks prior to treatment or planned during the study.
• • 16. History of alcohol/drug abuse.
• • 17. Pregnancy or lactation.
• • 18. Participation in another interventional clinical trial within 1 month prior to enrollment.
• • 19. Other factors deemed by investigators to potentially compromise efficacy/safety assessments.