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

NCT06925555 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-SR-050
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.

Conditions

EBV-Positive Diffuse Large B-Cell Lymphoma, Nos; Brentuximab Vedotin

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival (PFS) rate

  PFS was defined as the time between inclusion and the first date of progression, relapse, or death from any cause.

  2 years

Secondary Outcomes (3)

• ORR

  every 3 cycles, up to 6 cycles (each cycle is 21 days)

• CR rate

  every 3 cycles, up to 6 cycles (each cycle is 21 days)

• 2-year overall survival (OS) rate

  2 years

Study Arms (1)

BV+R-CHP Arm

EXPERIMENTAL

Newly Diagnosed EBV+ DLBCL-NOS Patients Receiving Brentuximab Vedotin plus R-CHP(Rituximab、Cyclophosphamide、Doxorubicin and Prednisone)

Drug: BV+R-CHP

Interventions

BV+R-CHP DRUG

Brentuximab Vedotin, 1.8mg/kg/dose, d0、Rituximab, 375 mg/m2, d0、Cyclophosphamide, 750 mg/m2, d1、Doxorubicin, 50 mg/m2, d1、Prednisone, 60mg/m2, d1-5

BV+R-CHP Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Wei Xu, Doctor

CONTACT

86-2568302182; xuwei10000@hotmail.com

Liang Jinhua, M.D

CONTACT

15952032421; 1151525490@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)