Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Recruiting at210 trial locations

Overseen by Sharon M Castellino

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.

Research Team

Sharon M Castellino

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for children and young adults with newly diagnosed Hodgkin lymphoma stages IIB (with bulk), IIIB, IVA, or IVB. Participants must have proper kidney function, normal bilirubin levels, healthy liver enzymes, good heart function, and acceptable lung capacity. They cannot join if they have certain types of immunodeficiency, are pregnant or breastfeeding, HIV positive, or have had previous cancer treatments.

Inclusion Criteria

Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by radionuclide angiogram

My lung function test shows I breathe well enough, unless it's due to a large chest tumor from Hodgkin Lymphoma.

My lung function test shows I can breathe out well.

Exclusion Criteria

Lactating females who plan to breastfeed

Sexually active patients of reproductive potential who have not agreed to use effective contraception

I have not taken systemic corticosteroids in the last 28 days.

Treatment Details

Interventions

• Brentuximab Vedotin (Monoclonal Antibodies)
• Cyclophosphamide (Alkylating agents)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic)
• Etoposide (Anti-metabolites)
• Methylprednisolone (Corticosteroid)
• Prednisone (Corticosteroid)
• Vincristine Sulfate (Vinca alkaloids)

Trial Overview The study is testing the effectiveness of brentuximab vedotin combined with chemotherapy against chemotherapy alone in treating high-risk Hodgkin lymphoma. The goal is to see if adding brentuximab vedotin improves treatment outcomes by targeting cancer cells more directly.

Participant Groups

Group I: ARM II (Bv-AVEPC) Experimental Treatment 11 Interventions

Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ABVE-PC) Active Control 11 Interventions

Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School