BrECADD Therapy for Hodgkin's Lymphoma

(BrECADD Trial)

Overseen By Michele Stanchina, DO

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

Must not be taking: Anthracyclines, Immunosuppressants, Corticosteroids, others

Disqualifiers: Cardiovascular disease, Autoimmune disorders, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of six drugs to evaluate their effectiveness for people with advanced Hodgkin's Lymphoma, a type of blood cancer. The drugs include Brentuximab Vedotin (an antibody-drug conjugate), Cyclophosphamide, Dacarbazine, Dexamethasone, Doxorubicin, and Etoposide. Researchers aim to understand the treatment's effectiveness and patient tolerance. They are also exploring whether a blood test can track patient responses to treatment. Ideal participants are those with Stage 2B to Stage IV Hodgkin's Lymphoma who have not received prior treatments for the cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the BrECADD treatment, which includes Brentuximab Vedotin and other medications, proved safe in earlier studies. When compared to another treatment called eBEACOPP, BrECADD demonstrated much better safety results, with fewer treatment-related issues. Patients generally tolerated the treatment well.

Moreover, Brentuximab Vedotin, a component of BrECADD, is already used in other approved treatments for Hodgkin's Lymphoma. This adds confidence in its safety, as it has been tested in similar contexts.

Overall, current evidence suggests that BrECADD is a well-tolerated option, with manageable side effects for patients who might join this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BrECADD therapy for Hodgkin's Lymphoma because it combines several powerful drugs, including Brentuximab Vedotin, which specifically targets cancer cells with a unique mechanism. Unlike traditional chemotherapies like ABVD or BEACOPP, Brentuximab Vedotin is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, potentially reducing damage to healthy cells. This targeted approach could lead to fewer side effects and improved outcomes for patients. Additionally, the combination of drugs in BrECADD may enhance the overall effectiveness against Hodgkin's Lymphoma by attacking the cancer in multiple ways simultaneously.

What evidence suggests that the BrECADD therapy could be effective for Hodgkin's Lymphoma?

Research has shown that BrECADD therapy, which participants in this trial will receive, effectively treats advanced Hodgkin's lymphoma. One study demonstrated that this drug combination worked well for younger patients with this cancer. Another study compared BrECADD to a different treatment and found it to be a strong option, especially when PET scans (a type of medical imaging) guided treatment. The BrECADD regimen includes several drugs that work together to attack cancer cells in different ways, aiming to improve patient outcomes. Overall, evidence suggests that BrECADD is a promising treatment choice for Hodgkin's lymphoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Michele Stanchina, DO

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with Stage 2 B-IV classical Hodgkin Lymphoma. Participants must have FDG-PET/CT scans showing active disease and an ECOG performance score of ≤2, indicating they can perform daily activities. They should not be pregnant and must agree to use effective contraception during the study.

Inclusion Criteria

I am a man and will use birth control with my partner who can have children.

I can take care of myself and am up and about more than half of the day.

My organs and bone marrow are functioning normally.

Exclusion Criteria

Breastfeeding or pregnant women

Hypersensitivity to brentuximab vedotin or study drug components

I am currently being treated for a serious infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BrECADD regimen, which includes Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival

16 months

What Are the Treatments Tested in This Trial?

Interventions

• Brentuximab Vedotin
• Cyclophosphamide
• Dacarbazine
• Dexamethasone
• Doxorubicin
• Etoposide

Trial Overview The BrECADD therapy being tested combines Brentuximab Vedotin with chemotherapy drugs (Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine) and a steroid (Dexamethasone). The trial aims to evaluate this regimen's effectiveness in treating Hodgkin Lymphoma stages 2B to IV.

How Is the Trial Designed?

Group I: BrECADD (Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, Dexamethasone) Experimental Treatment 6 Interventions

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).

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40674676/

A Prospective, Multicenter, Single-Arm, Phase II Cohort of ... ... doxorubicin, dacarbazine, and dexamethasone (BrECADD) is highly effective in younger patients with advanced-stage classic Hodgkin lymphoma (AS- ...

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)01315-1/fulltext

a randomised, multicentre, parallel, open-label, phase 3 trial Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21)

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07002216

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, ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO-25-00439

Positron Emission Tomography–Guided Brentuximab ... Positron emission tomography (PET)-guided therapy with 4-6 cycles of brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, ...

5. lymphomahub.com lymphomahub.com/medical-information/hd21-phase-iii-trial-fertility-outcomes-in-chl-with-brecadd-vs-ebeacopp

Fertility outcomes in cHL with BrECADD vs eBEACOPP Key data: BrECADD showed higher 4-year gonadal function recovery rates vs eBEACOPP in women (95.3% vs 73.3%; hazard ratio [HR], 1.69; 95% ...

6. takedaoncology.com takedaoncology.com/newsroom/news-releases/2025/europe-adcetris-approval

European Commission Approves ADCETRIS® ... The study met its co-primary safety and efficacy endpoints, with BrECADD demonstrating significantly superior safety as assessed by treatment-related morbidity ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318742/

Frontline brentuximab vedotin-based therapy for newly ... Clinical evidence shows that BV combined with AVD (doxorubicin, vinblastine, dacarbazine) yields superior survival outcomes compared to ABVD, ...

8. ashpublications.org ashpublications.org/blood/article/145/3/290/526323/Brentuximab-vedotin-nivolumab-doxorubicin-and

Brentuximab vedotin, nivolumab, doxorubicin, and ... Key PointsWith a median follow-up of 24.2 months, the 2-year progression-free survival of patients treated with AN+AD was 88%.AN+AD led to an 88% CR rate a.