Brentuximab + Chemotherapy for Hodgkin's Lymphoma

Recruiting at217 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Millennium Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for individuals with advanced classical Hodgkin Lymphoma who have measurable disease, are relatively active (ECOG <=2), and haven't started treatment yet. They must be diagnosed at a late stage (III or IV) according to Ann Arbor staging and confirmed by WHO classification.

Inclusion Criteria

My diagnosis is classical Hodgkin Lymphoma according to WHO standards.

I have Stage III or IV Hodgkin's lymphoma and haven't received any treatment.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have been diagnosed with a type of lymphoma called nodular lymphocyte predominant Hodgkin lymphoma.

I do not have brain or spinal cord disease, including PML.

I have nerve damage affecting my senses or movement.

Treatment Details

Interventions

• Bleomycin (Anti-tumor antibiotic)
• Brentuximab Vedotin (Monoclonal Antibodies)
• Dacarbazine (Anti-tumor antibiotic)
• Doxorubicin (Anti-tumor antibiotic)
• Vinblastine (Vinca alkaloids)

Trial Overview The study compares two treatments: A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine) against ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). It's designed to see which combination better prevents the cancer from progressing without getting worse.

Participant Groups

Group I: A + AVD Experimental Treatment 4 Interventions

A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.

Group II: ABVD Active Control 4 Interventions

ABVD consists of doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.

Bleomycin is already approved in Canada for the following indications:

Approved in Canada as Bleomycin for:

• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma
• Testicular cancer
• Ovarian cancer
• Malignant pleural effusions

Who Is Running the Clinical Trial?

Millennium Pharmaceuticals, Inc.

Lead Sponsor

Trials

406

Recruited

46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Seagen Inc.

Industry Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University