A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

Summary

The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease.

BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.

Conditions

• Hodgkin Lymphoma

Interventions

DRUG

Brentuximab vedotin

Brentuximab vedotin will be administered at 1.2 mg/kg IV on days 1 and 15 of each 28-day cycle

DRUG

Doxorubicin

Doxorubicin 25 mg/m\^2 IV

DRUG

Vinblastine

Vinblastine 6 mg/m\^2 IV

DRUG

Dacarbazine

Dacarbazine 375 mg/m\^2 IV on days 1 and 15 of each 28-day cycle

DRUG

Pembrolizumab

Pembrolizumab will be administered at 200 mg IV (flat) on day 1

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 IV (days 1 an

DRUG

Vinorelbine

Vinblastine 6 mg/m\^2 IV

DIAGNOSTIC_TEST

FDG-PET/CT scan

After 2 cycles of therapy, patients will undergo FDG-PET/CT scan

Sponsors & Collaborators

• Seagen Inc.

  collaborator INDUSTRY

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Robert Stuver, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-17

Primary Completion

2027-04-30

Completion

2027-04-30

FDA Drug

Yes

Countries

• United States

Study Locations