BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07002216
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab Vedotin — DRUG
    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.
  • Etoposide — DRUG
    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.
  • Cyclophosphamide — DRUG
    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.
  • Doxorubicin — DRUG
    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.
  • Dacarbazine — DRUG
    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.
  • Dexamethasone — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Oct 2025
Primary completion
Jul 15, 2030
Completion
Jul 15, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)
    Participants in this group will receive each component of the BrECADD regimen at the recommended dosage listed in the United States Package Inserts (USPIs). Total participation duration is up to 24 months (2 years).

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33146
Michele Stanchina, DO
[email protected]
1 (305) 243-5302
Michele Stanchina, DO (PRINCIPAL_INVESTIGATOR)
Craig Moskowitz, MD (PRINCIPAL_INVESTIGATOR)
Juan Alderuccio, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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