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

Last updated: April 18, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Marginal Zone Lymphoma

Hematologic Cancer

Treatment

Dacarbazine

Brentuximab vedotin

Vinorelbine

Clinical Study ID

NCT06377566
24-039
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histological diagnosis of classical, CD30-positive Hodgkin lymphoma confirmed atenrolling institution.

  • Ann Arbor stage I or II FDG-avid disease by FDG-PET/CT.

  • Disease bulk defined as any lymph node mass with transverse maximal diameter ≥ 7.0cm or coronal maximal diameter ≥ 7.0 cm on CT imaging.

  • Age 18 and over.

  • ECOG Performance Status ≤ 2

  • Females of childbearing age must be on an acceptable form of birth control perinstitutional standards during the treatment period.

  • Males must consistently use an acceptable form of contraception per institutionalstandards during the treatment period.

Exclusion

Exclusion Criteria:

  • Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excludingcorticosteroids)

  • Cardiac ejection fraction < 50% as measured by echocardiogram.

  • Platelet count ≤ 75,000/µL.

  • Hemoglobin level ≤ 7.0 mg/dL.

  • Absolute neutrophil count ≤ 1.0 K/µL.

  • Serum creatinine clearance < 30 mL/minute as estimated by the Cockcroft-GaultMethod.

  • Transaminase levels > 3 times the upper limit of normal in the absence of a historyof Gilbert's disease or hepatic involvement. In patients with Gilbert's disease, > 5times the upper limit of normal is exclusionary.

  • Total bilirubin ≥ 1.5 the upper limit of normal in the absence of a history ofGilbert's disease or hepatic involvement. In patients with Gilbert's disease, > 3times the upper limit of normal is exclusionary.

  • Pre-existing peripheral neuropathy ≥ grade 2 prior to participation.

  • Known pregnancy or breast-feeding

  • Active viral infection with hepatitis B or hepatitis C. For hepatitis B, patientswho are seropositive (hepatitis B core Ab positive) are permitted if HBV DNA isnegative by PCR. For hepatitis C, patients who are seropositive (hepatits C Abpositive) are eligible if HCV DNA is negative by PCR and curative therapy has beencompleted.

  • Concurrent malignancy requiring active therapy within the last 2 years with theexception of basal cell or squamous cell carcinoma limited to the skin, carcinoma insitu of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapyfor cancer previously treated for curative intent is permitted.

  • Patients with autoimmune conditions requiring active, ongoing systemicimmunosuppressive therapy.

  • Medical illness unrelated to Hodgkin lymphoma which in the opinion of the treatingphysician and/or principal investigator makes participation inappropriate.

Note: Patients with HIV infection are permitted to enroll but are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines concurrently with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine or ritonavir, cobicistat or similar potent CYP3 inhibitors are prohibited. In order to be eligible, patients taking zidovudine or ritonavir, or cobicistat or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. Subjects must be on HAART for at least 12 weeks prior to therapy.

Note: Patients with pre-existing autoimmune conditions are NOT excluded unless there is an autoimmune condition requiring active, ongoing systemic immunosuppressive therapy. However, careful consideration should be given to patients with pre-existing autoimmune conditions who may need pembrolizumab. Any concerns regarding patients with pre-existing autoimmune conditions and eligibility should be reviewed with the study PI.

Study Design

Total Participants: 71
Treatment Group(s): 8
Primary Treatment: Dacarbazine
Phase: 2
Study Start date:
April 17, 2024
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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