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

NCT ID: NCT06377566

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2027-04-30

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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)

All patients will receive 2 cycles of brentuximab vedotin (BV) in combination with AVD chemotherapy (doxorubicin, vinblastine, dacarbazine). Prophylactic growth factor support will be mandated with each cycle. After 2 cycles of therapy, patients will undergo FDG-PET/CT scan (PET2). Patients with disease progression (Deauville 4 or 5) will be taken off study. Patients who achieve a PETnegative scan (Deauville score of ≤ 3) will receive 2 additional cycles of BV-AVD with no further therapy. In those with partial response or stable disease (Deauville score of 4 or 5), patients will be stratified by baseline metabolic tumor volume (bMTV) as bMTV-high (\> 150 cm3 ) or bMTV-low (≤ 150 cm3 ) as measured on pre-treatment FDG-PET/CT. In the bMTV-low group, patients will receive an additional 2 cycles of BV-AVD in combination with radiation therapy.

Group Type: EXPERIMENTAL

Brentuximab vedotin

Intervention Type: DRUG

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

Doxorubicin

Intervention Type: DRUG

Doxorubicin 25 mg/m\^2 IV

Vinblastine

Intervention Type: DRUG

Vinblastine 6 mg/m\^2 IV

Dacarbazine

Intervention Type: DRUG

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

Pembrolizumab

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Vinorelbine

Intervention Type: DRUG

Vinblastine 6 mg/m\^2 IV

FDG-PET/CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Brentuximab vedotin

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

Intervention Type: DRUG

Doxorubicin

Doxorubicin 25 mg/m\^2 IV

Intervention Type: DRUG

Vinblastine

Vinblastine 6 mg/m\^2 IV

Intervention Type: DRUG

Dacarbazine

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

Intervention Type: DRUG

Pembrolizumab

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Vinorelbine

Vinblastine 6 mg/m\^2 IV

Intervention Type: DRUG

FDG-PET/CT scan

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Stuver, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

University of Miami

Miami, Florida, United States

Site Status: NOT_YET_RECRUITING

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert Stuver, MD

Role: CONTACT

stuverr@mskcc.org

646-608-4308

Alison Moskowitz, MD

Role: CONTACT

646-608-3726

Facility Contacts

Craig Moskowitz, MD

Role: primary

305-243-5302

Robert Stuver, MD

Role: primary

646-608-4308

Robert Stuver, MD

Role: primary

646-608-4308

Robert Stuver, MD

Role: primary

646-608-4308

Robert Stuver, MD

Role: primary

646-608-4308

Robert Stuver, MD

Role: primary

646-608-4308

Robert Stuver, MD

Role: primary

646-608-4308

Robert Stuver, MD

Role: primary

646-608-4308

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

24-039

Identifier Type: -

Identifier Source: org_study_id