New hope for hodgkin lymphoma: targeted drug combo shows promise in early trial
NCT ID NCT06377566
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether a combination of drugs called BV-AVD works well for people with newly diagnosed, early-stage bulky Hodgkin lymphoma. The study uses PET scans to guide treatment and includes about 71 participants. The goal is to see if this approach can stop the cancer from growing better than standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Brentuximab vedotin, doxorubicin, vinblastine, dacarbazine, pembrolizumab, gemcitabine, vinorelbine
- What this could lead to
- If successful, this could offer a more effective treatment option for people with early-stage bulky Hodgkin lymphoma, potentially improving their chances of staying cancer-free.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 71 participants, so results may not apply to everyone. The drug combination can cause side effects like nerve damage, low blood counts, and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 71 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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University of Miami
NOT_YET_RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Patient's own t cells engineered to hunt lymphoma in early trial
- Can early PET scans guide a gentler, more effective attack on hodgkin lymphoma?
- Can a calming drug make cord blood transplants safer?
- Can a new pill boost Immunotherapy's power against advanced tumors?