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Monoclonal Antibodies

BV-AVD 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

Must not have

Patients with autoimmune conditions requiring active, ongoing systemic immunosuppressive therapy

Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excluding corticosteroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on continuous medication for an autoimmune disease.

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I have had treatment other than steroids for Hodgkin lymphoma.

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My kidney function is reduced, with a creatinine clearance below 30 mL/min.

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I do not have severe numbness or pain in my hands or feet.

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My heart's pumping ability is below 50%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

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

~5410

Dacarbazine

2005

Completed Phase 3

~5350