NCT06377566 · Memorial Sloan Kettering Cancer Center
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Brentuximab vedotin
Brentuximab vedotin will be administered at 1.2 mg/kg IV on days 1 and 15 of each 28-day cycle
DRUG
Doxorubicin
Doxorubicin 25 mg/m\^2 IV
DRUG
Vinblastine
Vinblastine 6 mg/m\^2 IV
DRUG
Dacarbazine
Dacarbazine 375 mg/m\^2 IV on days 1 and 15 of each 28-day cycle
DRUG
Pembrolizumab
Pembrolizumab will be administered at 200 mg IV (flat) on day 1
DRUG
Gemcitabine
Gemcitabine 1000 mg/m\^2 IV (days 1 an
DRUG
Vinorelbine
Vinblastine 6 mg/m\^2 IV
DIAGNOSTIC_TEST
FDG-PET/CT scan
After 2 cycles of therapy, patients will undergo FDG-PET/CT scan
Primary outcome measures
progression-free survival
Time frame: 3 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Met
Where
- Miami, Florida
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Collaborators
Seagen Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations