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

ConditionsEBV-Positive Diffuse Large B-Cell Lymphoma, NosBrentuximab Vedotin
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: BV+R-CHP ArmExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

ORR

The Overall Response Rate

Time frame
every 3 cycles, up to 6 cycles (each cycle is 21 days)
2

CR rate

complete remission rate

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

2-year overall survival (OS) rate

Overall Survival: from the date of inclusion to date of death, irrespective of cause

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: