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Hodgkin LymphomaPhase 2BrECADDNCT07002216

BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma

A Phase 2 study testing Brentuximab Vedotin, Etoposide and Cyclophosphamide in people with Hodgkin Lymphoma and Advanced Hodgkin Lymphoma, run by University of Miami at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hodgkin Lymphoma, Advanced Hodgkin Lymphoma
What is being tested?
Brentuximab Vedotin, Etoposide and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
15 Jul 2025to 15 Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • 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.
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  • 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:
  • Absolute neutrophil count (ANC) >1,000 cells/mm3 independent of growth factor support within 7 days of study entry (≥750 cells/mm3 if lymphoma involvement of the bone marrow or spleen).
  • Platelets ≥75,000 platelets/mm3 independent of transfusion support within 7 days of study entry (≥50,000 platelets/mm3 independent of transfusion support within 7 days of study entry if lymphoma involvement of the bone marrow or spleen).
  • Hemoglobin >9 g/dL or >8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry.
  • Serum total bilirubin ≤2x upper limit of normal (ULN; except patients with Gilberts syndrome).
  • Aspartate aminotransferase (AST; serum glutamic-oxaloacetic transaminase) and alanine transaminase (ALT; serum glutamic-pyruvic transaminase) ≤2.5x institutional ULN (≤3x institutional ULN if lymphoma involvement of the liver).
  • Creatinine within normal institutional limits or creatinine clearance ≥40 mL/min (as estimated by the Cockcroft-Gault equation or alternative formula according to institutional guidelines) for patients with creatinine levels above institutional normal.
  • Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments (SoA).

Who cannot join

  • 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;
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  • 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.
  • Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
  • Active fungal, bacterial and/or viral infection requiring systemic therapy.
  • Breastfeeding or pregnant women.
  • Known active infection with human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection as follows:
  • Patients with positive HIV test and undetectable viral load will be eligible for this study.
  • Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb): Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (<20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation.
  • Presence of hepatitis C virus (HCV) antibody: Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable.
  • Patients with impaired decision-making capacity.
  • Underlying medical conditions that, in the Investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
  • Patients undergoing major surgery ≤4 weeks prior to receiving their first dose of BrECADD. Major surgery is defined as open-heart, reconstructive, transplant, removal of a brain tumor, or a damaged kidney surgery.
  • Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment.
  • Hypersensitivity to brentuximab vedotin, any components of the BrECADD regimen, or any of the other ingredients of the applicable study medications.
  • Concurrent participation in another therapeutic clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michele Stanchina, DO contact

+1 (305) 243-5302

mds331@med.miami.edu

Craig Moskowitz, MD contact

+ 1 (305) 243-9009

chm78@miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Miami, Florida, 33146

    Michele Stanchina, DO, 1 (305) 243-5302, mds331@med.miami.edu

    Michele Stanchina, DO

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine
Keywords
Stage 2 B-IV Hodgkin Lymphoma
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab VedotinDrug

    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.

  • EtoposideDrug

    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.

  • CyclophosphamideDrug

    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.

  • DoxorubicinDrug

    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.

  • DacarbazineDrug

    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.

  • DexamethasoneDrug

    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 groups in NCT07002216
Study groupRoleWhat they receive
BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone)ExperimentalParticipants 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).
Receives: Drug: Brentuximab Vedotin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Dacarbazine; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months

Secondary outcomes (5)

  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.

    Measured: Up to 24 months

  2. Number of Treatment-Related Adverse Events (AEs)

    The number of treatment-related AEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Standard definitions for seriousness will be applied.

    Measured: Up to 40 months

  3. Number of Treatment-Related Serious Adverse Events (SAEs)

    The number of treatment-related SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Standard definitions for seriousness will be applied.

    Measured: Up to 40 months

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

    Toxicity will be measured by the percentage of participants using the Participant Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). This criteria is a measurement system designed by the National Cancer Institute (NCI) to capture and evaluate the symptomatic side effects experienced by cancer patients during clinical trials, allowing patients to self-report on the frequency, severity, interference, and presence/absence of symptoms like pain, fatigue, nausea, and skin reactions, providing a more patient-centric perspective on treatment toxicity compared to clinician-based assessments alone.

    Measured: Up to 40 months

  5. Percentage of Participants With Toxicity Throughout BrECADD measured by FRAIL

    Toxicity will be measured by the percentage of participants using the Fatigue, Resistance, Aerobic Capacity, Illnesses and Loss of Weight (FRAIL) questionnaire.

    The FRAIL scale (short five-questions assessment of fatigue, resistance, aerobic capacity, illnesses and loss of weight) classified the patients into three categories: robust (score=0), pre-frailty (score=1-2), and frailty (score=3-5)

    Measured: Up to 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start15 Jul 2025
  3. Primary completion15 Jul 2030 (estimated)
  4. Study completion15 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002216
Sponsor's protocol ID
20250293
Acronym
BrECADD
Status last verified
Oct 2025
First submitted
23 May 2025
Last updated
3 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab Vedotin, Etoposide and Cyclophosphamide in people with Hodgkin Lymphoma and Advanced Hodgkin Lymphoma, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michele Stanchina, DO (+1 (305) 243-5302, mds331@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.

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