BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
Men and women ≥18 years of age and ≤60 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
Patients must have histologic confirmation of classical Hodgkin Lymphoma (cHL) defined by the World Health Organization (WHO) classification.
Baseline Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Computed Tomography (CT) must demonstrate Fluorodeoxyglucose (FDG) avid lesions compatible with computed tomography (CT)-defined anatomical tumor sites. Patients should have at least 1 measurable site of disease per Lugano classification in Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography (FDG-PET/CT) or CT scans.
Eastern Cooperative Oncology Group (ECOG) performance score (PS)≤ 2, except due to lymphoma involvement.
Disqualifiers
Stage I or Stage IIA (IIA) HL.
Nodular lymphocyte-predominant HL.
Prior systemic lymphoma therapy including prior treatment with brentuximab vedotin.
Myocardial infarction within 6 months before screening;
Trial design
Treatments tested in this trial
- Brentuximab Vedotin
- Etoposide
- Cyclophosphamide
- Doxorubicin
- Dacarbazine
- Dexamethasone
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Miami
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov