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New treatment option for Hodgkin Lymphoma
Official title A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT06377566
What this study is testing
What is Brentuximab vedotin?
Brentuximab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.