NCT07002216

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Lymphoma
• Advanced Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab 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.
DRUG	Etoposide	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.
DRUG	Cyclophosphamide	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.
DRUG	Doxorubicin	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.
DRUG	Dacarbazine	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.
DRUG	Dexamethasone	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.

Timeline

• Start date: 2025-07-15
• Primary completion: 2030-07-15
• Completion: 2030-07-15
• First posted: 2025-06-03
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study