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BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma

NCT07002216 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-11-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Michele Stanchina, DO · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2030-07-15
Completion
2030-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002216 on ClinicalTrials.gov