Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Millennium Pharmaceuticals, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for children with a new diagnosis of advanced stage Hodgkin Lymphoma, specifically stages III and IV. They should have CD30+ classical HL, not have received prior treatment, be relatively active (performance scores >=50), and have measurable disease by certain criteria. Their blood counts and kidney/liver functions must meet the study's standards.

Inclusion Criteria

My Hodgkin's lymphoma is in an advanced stage (Stage III or IV).

My Hodgkin's lymphoma is confirmed to be CD30 positive.

Your disease can be measured and seen on a scan using specific criteria.

Treatment Details

Interventions

• Brentuximab vedotin (Monoclonal Antibodies)
• Dacarbazine (Anti-metabolites)
• Doxorubicin (Anti-tumor antibiotic)
• Vinblastine (Vinca alkaloids)

Trial Overview The trial is testing Brentuximab Vedotin combined with a chemotherapy regimen including Doxorubicin (Adriamycin), Vinblastine, and Dacarbazine in pediatric patients. It aims to determine the safety, tolerability, proper dosage, and effectiveness against tumors in these young participants.

Participant Groups

Group I: Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Experimental Treatment 4 Interventions

Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.

Group II: Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD Experimental Treatment 4 Interventions

Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.

Brentuximab vedotin is already approved in Canada, Japan for the following indications:

Approved in Canada as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma

Approved in Japan as Adcetris for:

• Hodgkin lymphoma
• Anaplastic large cell lymphoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital Colorado Aurora, CO

Cincinnati Children's Hospital Medical Center Cincinnati, OH

Who Is Running the Clinical Trial?

Millennium Pharmaceuticals, Inc.

Lead Sponsor

Trials

406

Patients Recruited

46,900+

Takeda

Lead Sponsor

Trials

1255

Patients Recruited

4,219,000+