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NCT06377566 | RECRUITING | Hodgkin Lymphoma

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Hodgkin Lymphoma

Intervention/treatment

Brentuximab vedotin

Doxorubicin

Vinblastine

Dacarbazine

Pembrolizumab

Gemcitabine

Vinorelbine

FDG-PET/CT scan

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 71 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : BV-AVD in Patients With Newly-Diagnosed, Early Stage, Bulky Hodgkin Lymphoma Using a PET-adapted and MTV-guided Approach
Actual Study Start Date : 2024-04-17
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Histological diagnosis of classical, CD30-positive Hodgkin lymphoma confirmed at enrolling 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 ≥ 7.0 cm 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 per institutional standards during the treatment period.
  • * Males must consistently use an acceptable form of contraception per institutional standards during the treatment period.
Exclusion Criteria
  • * Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excluding corticosteroids)
  • * 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-Gault Method.
  • * Transaminase levels \> 3 times the upper limit of normal in the absence of a history of Gilbert's disease or hepatic involvement. In patients with Gilbert's disease, \> 5 times the upper limit of normal is exclusionary.
  • * Total bilirubin ≥ 1.5 the upper limit of normal in the absence of a history of Gilbert's disease or hepatic involvement. In patients with Gilbert's disease, \> 3 times 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, patients who are seropositive (hepatitis B core Ab positive) are permitted if HBV DNA is negative by PCR. For hepatitis C, patients who are seropositive (hepatits C Ab positive) are eligible if HCV DNA is negative by PCR and curative therapy has been completed.
  • * Concurrent malignancy requiring active therapy within the last 2 years with the exception of basal cell or squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapy for cancer previously treated for curative intent is permitted.
  • * Patients with autoimmune conditions requiring active, ongoing systemic immunosuppressive therapy.
  • * Medical illness unrelated to Hodgkin lymphoma which in the opinion of the treating physician 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.
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

Location Details

NCT06377566

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How to Participate

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Locations

NOT YET RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553