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Hodgkin LymphomaPhase 2NCT06377566

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

A Phase 2 study testing Brentuximab vedotin, Doxorubicin and Vinblastine in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Brentuximab vedotin, Doxorubicin and Vinblastine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
8 sitesUnited States
Study dates
17 Apr 2024to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Robert Stuver, MD contact

646-608-4308

stuverr@mskcc.org

Alison Moskowitz, MD contact

646-608-3726

8 sites in 1 country

United States8 sites, 8 recruiting

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Robert Stuver, MD, 646-608-4308

    Recruiting

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

    Commack, New York, 11725

    Robert Stuver, MD, 646-608-4308

    Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

    Robert Stuver, MD, 646-608-4308

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Craig Moskowitz, MD, 305-243-5302

    Not yet recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

    Robert Stuver, MD, 646-608-4308

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

    Robert Stuver, MD, 646-608-4308

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Robert Stuver, MD, 646-608-4308

    Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York, 11553

    Robert Stuver, MD, 646-608-4308

    Recruiting

Other trials in United States

About this study

Official title: BV-AVD in Patients With Newly-Diagnosed, Early Stage, Bulky Hodgkin Lymphoma Using a PET-adapted and MTV-guided Approach

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.

Being tested
Brentuximab vedotin, Doxorubicin, Vinblastine, Dacarbazine, Pembrolizumab
Keywords
Ann Arbor stage I or II, Brentuximab vedotin, Doxorubicin HCL, Vinblastine Sulfate, Dacarbazine, Pembrolizumab, Gemcitabine, Vinorelbine
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab vedotinDrug

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

  • DoxorubicinDrug

    Doxorubicin 25 mg/m^2 IV

  • VinblastineDrug

    Vinblastine 6 mg/m^2 IV

  • DacarbazineDrug

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

  • PembrolizumabDrug

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

  • GemcitabineDrug

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

  • VinorelbineDrug

    Vinblastine 6 mg/m^2 IV

  • FDG-PET/CT scanDiagnostic test

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

Study groups in NCT06377566
Study groupRoleWhat they receive
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)ExperimentalAll 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.
Receives: Drug: Brentuximab vedotin; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Pembrolizumab; Drug: Gemcitabine; Drug: Vinorelbine; Diagnostic Test: FDG-PET/CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    Measured: 3 years

Secondary outcomes (1)

  1. overall survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start17 Apr 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a multicenter, investigator-initiated, single-arm phase II trial.
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377566
Sponsor's protocol ID
24-039
Status last verified
Apr 2026
First submitted
17 Apr 2024
Last updated
23 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab vedotin, Doxorubicin and Vinblastine in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert Stuver, MD (646-608-4308, stuverr@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06377566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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