Actively Recruiting
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
260 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to further assess the efficacy and tolerability of a regimen of Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone (BrECADD) in patients with Stage 2 B-IV Hodgkin Lymphoma (HL) with an exploratory objective to assess the clinical utility of Circulating tumor DNA (ctDNA) as a biomarker for minimal residual disease (MRD) and depth of treatment response.
CONDITIONS
Official 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 informed 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 per Lugano classification.
- Clinical stage consistent with Stage 2 B cHL with risk factors (large mediastinal mass or extranodal disease), or Stage III or IV cHL based on Lugano criteria.
- Eastern Cooperative Oncology Group (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 treatment and for 6 months after.
- 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 defined by specific blood counts, liver enzymes, and kidney function within set limits.
- Ability to provide written informed consent and comply with study procedures and schedule.
You will not qualify if you...
- Stage I or Stage IIA Hodgkin Lymphoma.
- Nodular lymphocyte-predominant Hodgkin Lymphoma.
- Prior systemic lymphoma therapy including prior brentuximab vedotin treatment (except prior treatment for indolent lymphoma without anthracycline-based therapy).
- Uncontrolled or significant cardiovascular disease including recent myocardial infarction, unstable angina, severe heart failure, significant arrhythmias, or uncontrolled hypertension.
- Active autoimmune anemia or thrombocytopenia.
- Uncontrolled illnesses such as liver cirrhosis, diabetes, autoimmune disorders requiring high-dose immunosuppression, serious medical or psychiatric conditions.
- Severe or debilitating pulmonary disease.
- Peripheral neuropathy grade 2 or higher.
- Concurrent malignancy requiring active treatment.
- Prior malignancy within 3 years except certain treated skin, bladder, cervical, breast, or prostate cancers.
- Active infections requiring systemic therapy.
- Breastfeeding or pregnant women.
- Known active HIV infection or active hepatitis B or C infection unless viral loads are undetectable and monitoring is possible.
- Impaired decision-making capacity.
- Medical conditions that increase risk or interfere with study drug administration.
- Major surgery within 4 weeks before first dose of study drug.
- Live vaccination within 28 days before or during treatment.
- Hypersensitivity to study drugs or their components.
- Participation in another therapeutic clinical trial concurrently.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33146
Actively Recruiting
Research Team
M
Michele Stanchina, DO
CONTACT
C
Craig Moskowitz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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