Brentuximab + Chemotherapy for Hodgkin's Lymphoma

Palo Alto (17 mi)

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)

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

I have nerve damage affecting my senses or movement.

I am HIV positive.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: A + AVDExperimental Treatment4 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: ABVDActive Control4 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 European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Bleomycin for: