Not Yet RecruitingPhase 2

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

China25 participantsStarted 2025-09

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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).

2-year progression-free survival (PFS) rate

Timeframe: 2 years

NCT IDNCT06925555

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Wei Xu, Doctor

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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).