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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Brentuximab Vedotin
DrugParticipants will receive 1.8 mg/kg of Brentuximab Vedotin intravenously (IV) for up to 30 minutes on Day 1 of each 21-day cycle period for up to 4 cycles in accordance with institutional procedures.
Etoposide
DrugParticipants will receive 150 mg/m\^2 of Etoposide intravenously (IV) for up to 60 minutes on Days 1-3 of each 21-day cycle period for up to 4 cycles in accordance with institutional procedures.
Cyclophosphamide
DrugParticipants will receive 1250 mg/m\^2 of Cyclophosphamide intravenously (IV) for up to 60 minutes on Day 1 of each 21-day cycle period for up to 4 cycles in accordance with institutional procedures.
Doxorubicin
DrugParticipants will receive 40 mg/m\^2 of Doxorubicin intravenously (IV) for up to 30 minutes on Day 1 of each 21-day cycle period for up to 4 cycles in accordance with institutional procedures.
Dacarbazine
DrugParticipants will receive 250 mg/m\^2 of Dacarbazine intravenously (IV) for up to 120 minutes on Days 2-3 of each 21-day cycle period for up to 4 cycles in accordance with institutional procedures.
Dexamethasone
DrugParticipants will self-administer 40 mg of Dexamethasone orally on Days 1-4 of each 21-day cycle period for up to 4 cycles in accordance with institutional procedures.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)Experimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the elapsed time in months from the start of treatment until disease progression or death, whichever is earlier. Follow-up times for participants who remain alive without progression will be censored at the last documented disease assessment date.
Time frame
Up to 12 monthsSecondary outcomes
1
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the elapsed time in months from the start of treatment until disease progression or death, whichever is earlier. Follow-up times for participants who remain alive without progression will be censored at the last documented disease assessment date.
Time frame
Up to 24 months2
Number of Treatment-Related Adverse Events (AEs)
The number of treatment-related AEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Standard definitions for seriousness will be applied.
Time frame
Up to 40 months3
Number of Treatment-Related Serious Adverse Events (SAEs)
The number of treatment-related SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Standard definitions for seriousness will be applied.
Time frame
Up to 40 months4
Percentage of Participants With Toxicity Throughout BrECADD Measured by PRO-CTCAE
Toxicity will be measured by the percentage of participants using the Participant Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). This criteria is a measurement system designed by the National Cancer Institute (NCI) to capture and evaluate the symptomatic side effects experienced by cancer patients during clinical trials, allowing patients to self-report on the frequency, severity, interference, and presence/absence of symptoms like pain, fatigue, nausea, and skin reactions, providing a more patient-centric perspective on treatment toxicity compared to clinician-based assessments alone.
Time frame
Up to 40 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov