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Monoclonal Antibodies

Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Phase 3

Waitlist Available

Led By Sharon M Castellino

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

Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT) for children who are unable to cooperate

Patients with newly diagnosed, pathologically confirmed cHL meeting one of the following Ann Arbor stages: Stage IIB with bulk, Stage IIIB, Stage IVA, Stage IVB

Must not have

Patients known to be positive for HIV

Patients who have received previous chemotherapy or radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying brentuximab vedotin in combination with chemotherapy to see if it is more effective than chemotherapy alone in treating children with high risk Hodgkin lymphoma.

Who is the study for?

This trial is for children and young adults with newly diagnosed Hodgkin lymphoma stages IIB (with bulk), IIIB, IVA, or IVB. Participants must have proper kidney function, normal bilirubin levels, healthy liver enzymes, good heart function, and acceptable lung capacity. They cannot join if they have certain types of immunodeficiency, are pregnant or breastfeeding, HIV positive, or have had previous cancer treatments.

What is being tested?

The study is testing the effectiveness of brentuximab vedotin combined with chemotherapy against chemotherapy alone in treating high-risk Hodgkin lymphoma. The goal is to see if adding brentuximab vedotin improves treatment outcomes by targeting cancer cells more directly.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to the drugs used in this trial such as fatigue; nausea; hair loss; nerve damage that can cause pain or numbness; and increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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My lung function test shows I can breathe out well.

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My Hodgkin's lymphoma is at an advanced stage (IIB with bulk, IIIB, IVA, or IVB).

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My kidney function is normal or near normal.

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My bilirubin levels are within the normal range for my age.

Exclusion Criteria

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

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I am HIV positive.

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I have had chemotherapy or radiation therapy before.

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I have been diagnosed with nodular lymphocyte-predominant Hodgkin's lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 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

Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Secondary study objectives

Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

Other study objectives

Childhood International Prognostic Score (CHIPS) Score

Dose of Radiation Received by Normal Tissues Following Chemotherapy on Either Study Arm

Efficacy of Involved Site Radiotherapy (ISRT) by Analyzing the Event-free Survival of Patients Treated With Response-adapted ISRT and by Evaluating Patterns of Relapse Following ISRT

+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM II (Bv-AVEPC)Experimental Treatment11 Interventions

Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ABVE-PC)Active Control11 Interventions

Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 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

Cyclophosphamide

2010

Completed Phase 4

~2310