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Monoclonal Antibodies

Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 2

~200

Doxorubicin

2012

Completed Phase 3

~7940

Dacarbazine

2005

Completed Phase 3

~5110

Vinblastine

1998

Completed Phase 3

~5260

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

46,855 Total Patients Enrolled

TakedaLead Sponsor

1,205 Previous Clinical Trials

4,187,910 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,214 Previous Clinical Trials

499,455 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently eligible to apply for participation in this ongoing medical study?

"According to the information available on clinicaltrials.gov, this particular trial is no longer seeking participants. The initial posting of the trial was made on September 6th, 2017, and it was last edited on January 2nd, 2024. However, there are currently 1674 other trials that are actively enrolling patients at this time."

Answered by AI

Which specific group of individuals is considered most suitable for enrollment in this research study?

"In order to be eligible for this research study, potential participants must have a diagnosis of Hodgkin's lymphoma and fall within the age range of 5 to 17 years old. The trial aims to enroll approximately 59 individuals."

Answered by AI

Is there an age restriction for potential participants, specifically regarding individuals who are older than 25 years?

"Candidates between the ages of 5 and 17 are eligible for enrollment in this trial."

Answered by AI

Can you confirm if there are multiple locations conducting this research within the United States?

"This clinical trial is being conducted at various locations, including Azienda Ospedaliera Citta della Salute e della Scienza di Torino in Torino, Aichi-Ken, NHO Nagoya Medical Center in Nagoya-shi, Colorado, and Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia in Roma, Ohio. Additionally, there are 14 other participating sites involved in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

2017. "A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02979522.

All > Hodgkin Lymphoma