Actively Recruiting
BV-AVD Treatment in Newly-Diagnosed Early Stage Bulky Hodgkin Lymphoma Using a PET-Adapted and Tumor Volume-Guided Approach
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
71
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of brentuximab vedotin (BV) with AVD chemotherapy in people recently diagnosed with early stage, bulky Hodgkin lymphoma who have not yet received treatment. This Phase 2 study aims to see if adding BV, a targeted drug that attacks cancer cells expressing CD30, to standard chemotherapy can better slow or stop lymphoma growth compared to chemotherapy alone. The study is sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive two cycles of BV combined with AVD chemotherapy, supported by growth factor injections to help blood cell recovery. After these two cycles, patients undergo an FDG-PET/CT scan to assess response. Those with no progression receive two more cycles of BV-AVD without additional therapy. Patients with partial or stable disease are further assessed by tumor volume and may receive extra cycles of BV-AVD plus radiation if they have low tumor volume. Treatment doses and schedules involve intravenous administration on specific days within 28-day cycles. Throughout the study, participants have scans and clinical evaluations to monitor disease status and side effects. Researchers measure progression-free survival over three years as the primary outcome, with overall survival also tracked. Safety and response are closely observed, with patients leaving the study if disease progresses. The total participation period extends to several years for follow-up evaluations.
CONDITIONS
Brief Title
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 27 7.0 cm or coronal maximal diameter 27 7.0 cm on CT imaging.
- Age 18 and over.
- ECOG Performance Status 264 2.
- Females of childbearing age must use acceptable birth control during treatment.
- Males must consistently use acceptable contraception during treatment.
You will not qualify if you...
- Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excluding corticosteroids).
- Cardiac ejection fraction below 50% by echocardiogram.
- Platelet count 2c 75,000/bcL.
- Hemoglobin level 2c 7.0 mg/dL.
- Absolute neutrophil count 2c 1.0 K/bcL.
- Serum creatinine clearance below 30 mL/min by Cockcroft-Gault Method.
- Transaminase levels more than 3 times upper limit of normal, or 5 times if Gilbert's disease.
- Total bilirubin 2c 1.5 times upper limit of normal, or 3 times if Gilbert's disease.
- Pre-existing peripheral neuropathy grade 2 or higher.
- Known pregnancy or breastfeeding.
- Active hepatitis B or C infection unless controlled as specified.
- Concurrent malignancy requiring active therapy within last 2 years, excluding certain skin and localized cancers.
- Autoimmune conditions needing ongoing systemic immunosuppressive therapy.
- Medical illnesses making participation inappropriate as judged by physician or investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 6 months depending on response and treatment group
Participants receive 2 cycles of brentuximab vedotin combined with AVD chemotherapy, followed by an FDG-PET/CT scan to assess response. Depending on the scan results, participants may receive 2 additional cycles of BV-AVD or 2 more cycles with radiation therapy based on tumor volume.
Visits on days 1 and 15 of each 28-day cycle for drug administration, plus 1 imaging visit after 2 cycles
Trial Site Locations
Total: 8 locations
1
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
2
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
R
Robert Stuver, MD
A
Alison Moskowitz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here