Status:
NOT_YET_RECRUITING
Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
EBV-Positive Diffuse Large B-Cell Lymphoma, Nos
Brentuximab Vedotin
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.
Detailed Description
EBV-positive diffuse large B-cell lymphoma, not otherwise specified (EBV+ DLBCL-NOS), is an EBV-positive clonal B-cell lymphoid proliferation and circulating EBV-DNA is a great indicator for prognosis...
Eligibility Criteria
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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06925555
Start Date
September 1 2025
End Date
December 30 2028
Last Update
September 30 2025
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000