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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
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

Study 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.Check my eligibility
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.See study design
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.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Secondary outcome measures
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 outcome measures
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
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

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
Etoposide
2010
Completed Phase 3
~2440
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Vincristine Sulfate
2005
Completed Phase 3
~10110
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Methylprednisolone
2015
Completed Phase 4
~2280
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,553 Total Patients Enrolled
Sharon M CastellinoPrincipal InvestigatorChildren's Oncology Group

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02166463 — Phase 3
Hodgkin's Lymphoma Research Study Groups: Arm I (ABVE-PC), ARM II (Bv-AVEPC)
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT02166463 — Phase 3
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02166463 — Phase 3

Frequently Asked Questions

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

Are there any other drugs being tested in a similar way to this one?

"The first Pharmacological Study happened in 1997 at Spectrum Health Hospital - Butterworth Campus. So far, 3046 studies have completed and there are currently 1497 active trials. A large portion of these ongoing experiments are based out of Asheville, North carolina."

Answered by AI

Does this study have an age limit? If so, what is it?

"The age bracket for this study is 2-22 years old."

Answered by AI

What patients does this medication usually help?

"Pharmacological Study is a medication used to treat prostate cancer, but it can also be effective in managing pheochromocytomas, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Could you please elaborate on the potential risks of this medication?

"Given that this is a Phase 3 trial with evidence of efficacy and safety from multiple rounds of testing, our team at Power has rated the safety of Pharmacological Study to be a 3."

Answered by AI

Are there a few hospitals running this test in the area?

"There are 100 enrollees for this clinical trial at Mission Hospital in Asheville, University of Illinois in Chicago, Cardinal Glennon Children's Medical Center in Saint Louis, and other locations."

Answered by AI

Is this a new clinical trial?

"Since 1997, there has been an ongoing effort to study Pharmacological Study. The firstsponsored by Alfacell was in 1997 and it involved 300 participants. After this initial research project, Phase 3 drug approval was given. As of now, there are 1497 active studies being conducted in 81 different countries across 3085 cities."

Answered by AI

Are we still enrolling patients for this clinical trial?

"This study is no longer active. The listing for this research was first posted on March 16th, 2015 and edited September 16th, 2022. However, there are other ongoing trials which may be of interest; currently, 1765 studies are actively recruiting patients with Ann Arbor Stage IV Hodgkin Lymphoma and 1497 Pharmacological Studies have open enrollment."

Answered by AI

How many people are eligible for this research project?

"Unfortunately, this study is not currently admitting patients. Although, it is worth noting that the trial was first posted on 3/16/2015 and was most recently updated on 9/16/2022. If you are willing to consider other options, there are presently 1765 studies actively admitting participants with ann arbor stage iv hodgkin lymphoma and 1497 trials for Pharmacological Study actively searching for patients."

Answered by AI

Are people with pre-existing conditions able to join this research project?

"This study requires 597 young patients, aged 2-22, who have been diagnosed with stage IV Hodgkin lymphoma. In order to be eligible for the trial, patients must also meet at least one of the following additional criteria: Stage IIB with bulk, Stage IIIB, Stage IVA, or Stage IVB. If a patient's eligibility is unclear based on staging alone, they may consult with Imaging and Radiation Oncology Core (IROC) Rhode island (RI) prior to enrolling in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
2015. "Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02166463.
~60 spots leftby Apr 2025
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