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Monoclonal Antibodies

Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Paul G Rubinstein

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Other strong CYP3A inhibitors

Patients diagnosed with hepatitis C who are hepatitis C antibody positive, whether hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests

Must not have

Central nervous system disease

Patients with history of John Cunningham (JC) virus identified in the cerebrospinal fluid (CSF) or previous history of PML will be excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying brentuximab vedotin given together with combination chemotherapy to see how well it works in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma.

Who is the study for?

This trial is for HIV-positive patients with stage II-IV Hodgkin lymphoma who haven't had certain treatments. They must be on antiretroviral therapy, have adequate organ function, and agree to use contraception. Excluded are those with severe neuropathy, central nervous system disease, cirrhosis, recent heart issues or other serious medical conditions.

What is being tested?

The trial tests brentuximab vedotin combined with chemotherapy (doxorubicin hydrochloride, vinblastine sulfate, dacarbazine) in treating HIV-associated Hodgkin lymphoma. It aims to determine the best dose of brentuximab and how well it works alongside standard chemo drugs.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to the drug infusion, nerve damage (neuropathy), fatigue, nausea or vomiting from chemotherapy drugs used in treatment. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am not taking strong CYP3A inhibitors.

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I have hepatitis C without cirrhosis and normal liver function tests.

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My Hodgkin lymphoma is CD30-positive, not the nodular type.

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My heart pumps blood well, with an ejection fraction of 50% or higher.

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My kidney function is normal, with creatinine levels at or below 1.5 mg/dL or clearance above 60 mL/min if higher.

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I am taking medication for low blood cell counts due to HIV.

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I have stopped taking certain medications a week before starting chemotherapy.

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I have records of receiving HIV treatment from a licensed healthcare provider.

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I am taking strong medications for HIV.

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I am not taking any P-glycoprotein inhibitors.

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My condition is at stage II, III, or IV according to the Ann Arbor system.

Exclusion Criteria

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

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I have a condition affecting my brain or spinal cord.

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I have never had the JC virus or PML.

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I do not have cirrhosis.

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I experience significant numbness or pain in my hands or feet.

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I have never received anthracycline therapy.

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My MRI shows my brain disease is getting worse.

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I am not pregnant or breastfeeding, confirmed by a test if applicable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

2-year Progression-free Survival (PFS)

Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)

Secondary study objectives

2-year Overall Survival

CD4 Counts

CD8 Counts

+11 more

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: Treatment (brentuximab and combination chemotherapy)Experimental Treatment5 Interventions

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brentuximab Vedotin

2015

Completed Phase 3

~1080

Dacarbazine

2005

Completed Phase 3

~5350