RecruitingPhase 2NCT07002216

BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma

A Phase 2 Trial of Abbreviated Brentuximab Vedotin, Etoposide, Cyclophosphamide, Adriamycin, Dacarbazine, and Dexamethasone (BrECADD) Therapy in Stage 2 B-IV Hodgkin Lymphoma

Sponsor

University of Miami

Enrollment

48 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Hodgkin Lymphoma Advanced Hodgkin Lymphoma

Summary

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing BrECADD — a combination chemotherapy regimen — as a first-line treatment for people with advanced Hodgkin lymphoma (a cancer of the lymphatic system) to see whether it is effective and well-tolerated. **You may be eligible if...** - You are 18–60 years old with a confirmed diagnosis of classical Hodgkin lymphoma (cHL) - You have stage IIB disease with a large mass or cancer outside lymph nodes, or stage III/IV disease - You have not received prior treatment for Hodgkin lymphoma - You are in reasonably good health (ECOG 0–2) - Your cancer shows up on PET/CT imaging **You may NOT be eligible if...** - You have had prior treatment for Hodgkin lymphoma - You have serious heart, liver, or kidney problems - You have active infections or autoimmune conditions that contraindicate treatment - You are pregnant or plan to become pregnant during or within 6 months of treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrentuximab Vedotin

Participants 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.

DRUGEtoposide

Participants 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.

DRUGCyclophosphamide

Participants 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.

DRUGDoxorubicin

Participants 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.

DRUGDacarbazine

Participants 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.

DRUGDexamethasone

Participants 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.