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Monoclonal Antibodies

Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Millennium Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Advanced stage, newly diagnosed HL (Stage III and Stage IV disease).

Histologically confirmed CD30+ classical HL.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if a combination of brentuximab vedotin and chemotherapy is safe and effective in treating children with advanced stage Hodgkin Lymphoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea or vomiting from chemotherapy drugs; low blood cell counts leading to increased infection risk or bleeding problems; potential liver or kidney issues; nerve damage may occur due to Brentuximab Vedotin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am mostly active and can carry out daily activities.

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I have never received treatment for Hodgkin lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Percentage of Participants Who Experienced Adverse Events (AEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy

Phase 1: Percentage of Participants Who Experienced Serious Adverse Events (SAEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy

Phase 1: Recommended Dose of Brentuximab Vedotin in Combination With Doxorubicin, Vinblastine, and Dacarbazine in a Pediatric Population

+5 more

Secondary study objectives

Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants

Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE

Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb

+46 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVDExperimental Treatment4 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 + AVDExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brentuximab vedotin

2012

Completed Phase 4

~210

Doxorubicin

2012

Completed Phase 3