Study on BV-AVD Treatment for People with Bulky Hodgkin Lymphoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06377566

Provider View

This clinical trial is testing a new treatment called BV-AVD for people with early stage, bulky Hodgkin lymphoma who have not yet received any treatment. The study aims to see if this combination can effectively slow or stop the growth of cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new treatment called BV-AVD is effective for people with early stage, bulky Hodgkin lymphoma that has been recently diagnosed and not yet treated. BV is a special type of drug that targets cancer cells with a protein called CD30, which helps the cancer grow. By targeting these cells, BV may help slow or stop the cancer. AVD is a combination of drugs that work by stopping cancer cells from growing or dividing. Researchers believe that using BV with AVD might be more effective than using AVD alone.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with classical, CD30-positive Hodgkin lymphoma.
  • Cancer is in early stages (I or II) and shows up on specific scans.
  • Have a large lymph node mass (7 cm or larger) as seen on scans.
  • Age 18 or older.
  • In good overall health with a performance status of 2 or less.
  • Women of childbearing age must use effective birth control during treatment.
  • Men must use effective contraception during treatment.

Exclusion Criteria

  • Have received any previous treatment for Hodgkin lymphoma, except corticosteroids.
  • Heart function below 50%.
  • Low platelet count (75,000/µL or less).
  • Low hemoglobin level (7.0 mg/dL or less).
  • Low neutrophil count (1.0 K/µL or less).
  • Poor kidney function (creatinine clearance below 30 mL/minute).
  • High liver enzyme levels (more than 3 times the normal limit, or 5 times for those with Gilbert's disease).
  • High bilirubin levels (1.5 times the normal limit, or 3 times for those with Gilbert's disease).
  • Existing nerve damage (grade 2 or higher).
  • Pregnant or breastfeeding.
  • Active hepatitis B or C infection, unless under control.
  • Another active cancer requiring treatment in the last 2 years, except for certain skin cancers or localized prostate cancer.
  • Autoimmune conditions needing ongoing immunosuppressive therapy.
  • Other medical conditions that make participation inappropriate.

Note: People with HIV can participate if they are on a stable antiretroviral regimen. Certain medications are not allowed, and changes may be needed before starting the study. Patients with autoimmune conditions can participate unless they require ongoing immunosuppressive therapy. Any concerns should be discussed with the study team.

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