BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma

NCT07002216 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20250293
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stage 2 B-IV Hodgkin Lymphoma

Outcome Measures

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.

  Up to 12 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 24 months

• Number of Treatment-Related Adverse Events (AEs)

  Up to 40 months

• Number of Treatment-Related Serious Adverse Events (SAEs)

  Up to 40 months

• Percentage of Participants With Toxicity Throughout BrECADD Measured by PRO-CTCAE

  Up to 40 months

• Percentage of Participants With Toxicity Throughout BrECADD measured by FRAIL

  Up to 40 months

Study Arms (1)

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

EXPERIMENTAL

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).

Drug: Brentuximab Vedotin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Dacarbazine; Drug: Dexamethasone

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.

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

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.

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

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.

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

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.

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

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.

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

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.

BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patients must have a clinical stage consistent with:
• a. Stage 2 B cHL with one or both of the following risk factors: i. Large mediastinal mass (≥1/3 of the maximum transverse thoracic diameter) ii. Extranodal disease b. Stage III or Stage IV cHL based on Lugano criteria based on FDG-PET/CT.
• Eastern Cooperative Oncology Group (ECOG) performance score (PS)≤ 2, except due to lymphoma involvement.
• Life expectancy ≥3 months.
• Women should avoid becoming pregnant for the full duration of chemotherapy and for up to 6 months after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures during treatment and for up to 6 months after stopping treatment. It is currently unknown whether brentuximab vedotin may reduce the effectiveness of hormonal contraceptives, and therefore, women using hormonal contraceptives should add a barrier method. Pregnancy testing is recommended for women of reproductive potential prior to initiating therapy.
• Agreement to use contraception during study participation.
• Female patients of childbearing potential must use highly effective methods of contraception.
• Patients using hormonal contraceptives (eg, birth control pills or devices) must use a barrier method of contraception (eg, condoms) as well.
• A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
• A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.
• Male patients with a female partner of childbearing potential are eligible if they abstain from sexual intercourse, are vasectomized, or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for 120 days after the last dose of brentuximab vedotin.
• Patients must have normal organ and marrow function as defined below:

You may not qualify if:

• Stage I or Stage IIA (IIA) HL.
• Nodular lymphocyte-predominant HL.
• Prior systemic lymphoma therapy including prior treatment with brentuximab vedotin.
• Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive anthracycline-based therapy.
• Any uncontrolled or clinically significant cardiovascular disease including the following:
• Myocardial infarction within 6 months before screening;
• Unstable angina within 3 months before screening;
• New York Heart Association class III or IV congestive heart failure;
• History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes).
• Uncontrolled hypertension as indicated by ≥2 consecutive blood pressure measurements showing systolic blood pressure \>170 mm Hg and/or diastolic blood pressure \>105 mm Hg at screening.
• Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
• Uncontrolled concurrent illness, such as liver cirrhosis, diabetes, autoimmune disorder requiring immunosuppression or long-term corticosteroids (\>10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness which would compromise ability to comply with study procedures.
• Severe or debilitating pulmonary disease.
• Peripheral neuropathy ≥Grade 2.
• Concurrent malignancy requiring active therapy.

Sponsors & Collaborators

• University of Miami: lead
• Pfizer: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin; Etoposide; Cyclophosphamide; Doxorubicin; Dacarbazine; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Michele Stanchina, DO

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Stanchina, DO

CONTACT

+1 (305) 243-5302; mds331@med.miami.edu

Craig Moskowitz, MD

CONTACT

+ 1 (305) 243-9009; chm78@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2030
• Study Completion (Estimated): July 15, 2030
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)