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Monoclonal Antibodies

Brentuximab Vedotin Combination for Hodgkin's Lymphoma

Praha 10, Czechia

Phase 2

Waitlist Available

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

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

Must have

Participants enrolling in Part B of the study must have Ann Arbor Stage I or II cHL with bulky mediastinal disease, or Stage III or IV

Participants enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky disease

Must not have

Nodular lymphocyte predominant HL

History of a cerebral vascular event within 6 months of the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 33.8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C). Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD."

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Who is the study for?

This trial is for individuals with classical Hodgkin lymphoma (cHL) who haven't had treatment before. Participants must have specific stages of cHL as defined by the Ann Arbor classification, measurable disease, and be at least 12 years old in the US or 18 elsewhere. They should also have a performance status that allows daily activity.Check my eligibility

What is being tested?

The trial tests two drug combinations: 'A+AVD' (brentuximab vedotin with doxorubicin, vinblastine, dacarbazine) and 'AN+AD' (brentuximab vedotin with nivolumab, doxorubicin, dacarbazine). It aims to see how well these treatments work and what side effects they cause over several cycles.See study design

What are the potential side effects?

Potential side effects include febrile neutropenia (fever with low white blood cell count), which can be life-threatening. Other risks may involve reactions to drugs like fatigue, infection risk increase due to low immunity cells, nerve damage symptoms like numbness or tingling.

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 either early stage with a large tumor in my chest or is advanced.

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My Hodgkin's lymphoma is in the early stages and not widespread.

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My Hodgkin's lymphoma diagnosis is confirmed by tissue analysis.

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My cancer can be measured in two dimensions on scans.

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I can care for myself and am up and about more than 50% of my waking hours.

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My cancer is at an advanced stage (Stage III or IV).

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I have classic Hodgkin lymphoma and have not received any treatment.

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Exclusion Criteria

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

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My condition is nodular lymphocyte predominant Hodgkin lymphoma.

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I have not had a stroke or similar brain event in the last 6 months.

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My cancer has spread to my brain or its coverings.

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I haven't had a severe infection in the last two weeks.

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I am not on any other cancer treatments or experimental drugs.

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I do not have active lung disease that could affect my treatment.

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I have a history of lung scarring or my lungs are less effective at exchanging gases.

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My liver function is moderately to severely impaired.

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I am experiencing graft-versus-host disease or am on immunosuppressive therapy for it.

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I have moderate to severe numbness, tingling, or muscle weakness.

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I have a severe lung condition not caused by my cancer.

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I have been treated with brentuximab vedotin before.

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I have been treated with specific immune system targeting drugs.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 33.8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~33.8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 33.8 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

Complete Response (CR) Rate (Parts B and C)

Febrile Neutropenia (FN) Rate (Part A)

Secondary study objectives

Complete Response Rate (Part A)

Incidence of Laboratory Abnormalities (Parts B and C)

Overall Response Rate (ORR) at EOT (Parts B and C)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C: AN+ADExperimental Treatment4 Interventions

Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.

Group II: Part B: AN+ADExperimental Treatment4 Interventions

Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle.

Group III: Part A: A+AVDExperimental Treatment5 Interventions

Brentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion in participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

brentuximab vedotin

2010

Completed Phase 3

~1900

doxorubicin

2005

Completed Phase 3

~9130