Actively Recruiting
A Phase 2 Trial of BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma
Led by University of Miami · Updated on 2025-11-03
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and tolerability of a treatment regimen called BrECADD, which includes Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone, in patients with Stage 2 B-IV Hodgkin Lymphoma. The study also explores the use of circulating tumor DNA (ctDNA) as a biomarker to monitor minimal residual disease and treatment response depth. This is a Phase 2 clinical trial supported by the University of Miami. Participants will receive the BrECADD regimen following recommended doses from United States Package Inserts. Brentuximab Vedotin is given intravenously on Day 1 of each 21-day cycle for up to 4 cycles. Etoposide is administered intravenously on Days 1-3, Cyclophosphamide and Doxorubicin intravenously on Day 1, Dacarbazine intravenously on Days 2-3, and Dexamethasone is self-administered orally on Days 1-4 of each cycle. Total participation lasts up to 24 months. During the study, participants will undergo assessments including scans and laboratory tests to monitor tumor response and side effects. Researchers will measure progression-free survival at 12 months as the primary outcome and evaluate safety through the number of adverse events and treatment toxicity up to 40 months. Participants will provide informed consent and be monitored regularly throughout the trial period.
CONDITIONS
Brief Title
BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 60 years at the time of consent
- Histologic confirmation of classical Hodgkin Lymphoma (cHL) as defined by WHO classification
- Baseline FDG-PET/CT showing FDG avid lesions with at least one measurable disease site
- Clinical stage 2 B cHL with risk factors or stage 3 or 4 cHL according to Lugano criteria
- ECOG performance score of 2 or less, except due to lymphoma involvement
- Life expectancy of at least 3 months
- Women of childbearing potential must use highly effective contraception during and for 6 months after treatment
- Male patients with female partners of childbearing potential must use barrier contraception or abstain during treatment and for 120 days after last dose
- Normal organ and marrow function as defined by specific blood counts and liver and kidney function tests
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- Stage 1 or stage 2A Hodgkin Lymphoma
- Nodular lymphocyte-predominant Hodgkin Lymphoma
- Prior systemic lymphoma therapy including brentuximab vedotin
- Uncontrolled or serious cardiovascular diseases such as recent myocardial infarction, unstable angina, severe heart failure, or significant arrhythmias
- Uncontrolled hypertension with blood pressure readings above specified limits
- Active autoimmune anemia or thrombocytopenia
- Uncontrolled illness including liver cirrhosis, diabetes, autoimmune disorders requiring immunosuppression, or serious psychiatric illness
- Severe or debilitating lung disease
- Peripheral neuropathy grade 2 or higher
- Concurrent active malignancy requiring treatment
- Prior malignancy within 3 years except certain treated skin, bladder, cervical, breast, or prostate cancers
- Active infections requiring systemic therapy
- Pregnant or breastfeeding women
- Known active HIV or active hepatitis B or C infections without controlled viral loads
- Impaired decision-making capacity
- Medical conditions that increase risk or interfere with study treatment
- Major surgery within 4 weeks before first dose
- Recent live vaccination within 28 days before or during treatment
- Hypersensitivity to any study drug components
- Participation in another therapeutic clinical trial concurrently
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 - Up to 12 weeks
Participants receive the BrECADD regimen consisting of Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone in 21-day cycles for up to 4 cycles.
Up to 4 treatment cycles every 21 days with multiple infusion visits per cycle
Duration - Up to 40 months
Participants are monitored for progression-free survival and treatment-related adverse events after completing treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33146
Actively Recruiting
Research Team
M
Michele Stanchina, DO
C
Craig 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