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Monoclonal Antibodies

BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine) for Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Robert Stuver, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Disease bulk defined as any lymph node mass with transverse maximal diameter ≥ 7.0 cm or coronal maximal diameter ≥ 7.0 cm on CT imaging

Histological diagnosis of classical, CD30-positive Hodgkin lymphoma confirmed at enrolling institution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

"This trial aims to test if BV-AVD is an effective treatment for people with early-stage, bulky Hodgkin lymphoma who have not yet received any treatments. BV is a drug that targets cancer cells

Who is the study for?

This trial is for people who have just been diagnosed with early stage, bulky Hodgkin lymphoma and haven't started treatment yet. They should be able to undergo the treatments being tested.Check my eligibility

What is being tested?

The study tests BV-AVD, a combination of an antibody-drug conjugate called Brentuximab vedotin (BV) and chemotherapy drugs doxorubicin, vinblastine, and dacarbazine (AVD). It aims to see if this mix works better than standard therapy in treating Hodgkin lymphoma.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, hair loss from chemotherapy drugs; Brentuximab may cause nerve damage or low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My lymph node mass is larger than 7 cm as shown on a CT scan.

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My Hodgkin lymphoma is CD30-positive as confirmed by my hospital.

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My lymphoma is in the early stages and shows up on special body scans.

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I am 18 years old or older.

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

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I am using reliable birth control methods during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

progression-free survival

Secondary outcome measures

overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)Experimental Treatment8 Interventions

All patients will receive 2 cycles of brentuximab vedotin (BV) in combination with AVD chemotherapy (doxorubicin, vinblastine, dacarbazine). Prophylactic growth factor support will be mandated with each cycle. After 2 cycles of therapy, patients will undergo FDG-PET/CT scan (PET2). Patients with disease progression (Deauville 4 or 5) will be taken off study. Patients who achieve a PETnegative scan (Deauville score of ≤ 3) will receive 2 additional cycles of BV-AVD with no further therapy. In those with partial response or stable disease (Deauville score of 4 or 5), patients will be stratified by baseline metabolic tumor volume (bMTV) as bMTV-high (> 150 cm3 ) or bMTV-low (≤ 150 cm3 ) as measured on pre-treatment FDG-PET/CT. In the bMTV-low group, patients will receive an additional 2 cycles of BV-AVD in combination with radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinblastine

1998

Completed Phase 3

~5260

Vinorelbine

2013

Completed Phase 4

~2190

Brentuximab vedotin

2012

Completed Phase 2

~200

FDG-PET/CT scan

2012

N/A

~20

Doxorubicin

2012

Completed Phase 3

~7940

Dacarbazine

2005

Completed Phase 3

~5110

Pembrolizumab

2017

Completed Phase 2

~2010

Gemcitabine

2017

Completed Phase 3

~2070

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,811 Total Patients Enrolled

Seagen Inc.Industry Sponsor

208 Previous Clinical Trials

74,157 Total Patients Enrolled

Robert Stuver, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

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

Are they currently accepting participants for this research study?

"Indeed, as per clinicaltrials.gov, this trial is presently seeking eligible participants. The study was initially made public on April 17th, 2024, and the most recent update was also on that date. A total of 71 individuals are sought from across eight distinct locations for enrollment in this trial."

Answered by AI

What are the potential risks associated with BV-AVD therapy for individuals undergoing treatment?

"The safety of BV-AVD is rated at 2 by our team at Power, as per the Phase 2 trial stage. At this point, there is existing safety data available but no efficacy data to support its use."

Answered by AI

Are there several sites conducting this study within the state?

"The clinical trial is currently active at various sites including Memorial Sloan Kettering Bergen in Montvale, Memorial Sloan Kettering Cancer Center in New york, and Memorial Sloan Kettering Nassau in Uniondale. Additionally, there are 8 more locations where the trial is being conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

2024. "A Study of BV-AVD in People With Bulky Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06377566.

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