RecruitingPhase 2NCT06377566

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

71 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination called BV-AVD (which includes brentuximab vedotin) for people with bulky early-stage Hodgkin lymphoma — meaning the cancer has not spread far but has at least one large tumor mass. **You may be eligible if...** - You are 18 or older - You have been diagnosed with classical Hodgkin lymphoma that is CD30-positive (confirmed by your treatment center) - Your disease is stage I or II (early stage) and has not spread widely - You have at least one large lymph node mass (7 cm or larger) - You have not received any prior treatment for Hodgkin lymphoma - Your heart function is adequate (ejection fraction 50% or higher) **You may NOT be eligible if...** - You have already received chemotherapy or radiation for Hodgkin lymphoma (excluding short courses of steroids) - Your heart function is below the required level - You have other conditions that make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrentuximab vedotin

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

DRUGDoxorubicin

Doxorubicin 25 mg/m\^2 IV

DRUGVinblastine

Vinblastine 6 mg/m\^2 IV

DRUGDacarbazine

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

DRUGPembrolizumab

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

DRUGGemcitabine

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

DRUGVinorelbine

Vinblastine 6 mg/m\^2 IV

DIAGNOSTIC_TESTFDG-PET/CT scan

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


Locations(8)

University of Miami

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06377566


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