NCT06377566

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

BV-AVD in Patients With Newly-Diagnosed, Early Stage, Bulky Hodgkin Lymphoma Using a PET-adapted and MTV-guided Approach

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-04-17
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-04-22
• Last updated: 2025-04-20

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study