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Monoclonal Antibodies

Ibrutinib + Brentuximab Vedotin for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Alex Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically documented or cytologically confirmed Hodgkin lymphoma with CD30 expression
Patients must be either refractory to or relapsed after 1 line of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights

Study Summary

This trial is testing ibrutinib and brentuximab vedotin to see if they are effective in treating patients with Hodgkin lymphoma that has returned or does not respond to treatment.

Who is the study for?
This trial is for adults with relapsed or refractory Hodgkin lymphoma, who have tried at least one treatment before. They must have a certain level of blood cells and organ function, agree to use contraception, and not be pregnant. People can't join if they weigh less than 40 kg, have severe illnesses or infections, are on certain drugs that affect the liver enzyme CYP3A4/5, or had bad reactions to similar drugs.Check my eligibility
What is being tested?
The trial tests combining Ibrutinib (which blocks enzymes for cell growth) with Brentuximab Vedotin (an antibody that helps the immune system attack cancer). It's for patients whose Hodgkin lymphoma has come back after treatment or hasn't responded to previous treatments.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medications used in this study. Ibrutinib may cause bleeding problems, heart rhythm issues, infections among others. Brentuximab Vedotin might lead to nerve damage (neuropathy), infusion reactions like fever and chills as well as low blood cell counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Hodgkin lymphoma has been confirmed and shows CD30 expression.
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My condition did not improve or worsened after one treatment.
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My condition did not improve or worsened after one treatment.
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I have never taken ibrutinib for Hodgkin lymphoma.
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I weigh more than 40 kg and am expected to live more than 3 months.
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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) Rate
Secondary outcome measures
Overall Response Rate (ORR)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 daysExperimental Treatment2 Interventions
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 daysExperimental Treatment2 Interventions
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Brentuximab Vedotin
2015
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,413 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,607 Total Patients Enrolled
Alex HerreraPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
77 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned Ibrutinib as a viable medical remedy?

"Due to a lack of efficacy data, our team has placed Ibrutinib on the conservative side with a safety rating of 2."

Answered by AI

For what ailment is Ibrutinib typically prescribed?

"To treat cell transplants, chronic lymphocytic leukemia (CLL), and Hodgkin Disease, ibrutinib offers a viable solution."

Answered by AI

How many participants have been enrolled in this experiment?

"Unfortunately, recruitment for this medical study has ceased. The trial was initially posted on June 20th 2016 and its most recent update occurred on September 1st 2022. For those seeking alternative studies, there are presently 1724 clinical trials in search of patients with hodgkin disease as well as 213 separate trails searching for participants to take Ibrutinib."

Answered by AI

Are there any additional investigations involving Ibrutinib?

"Currently, 213 studies are ongoing that focus on ibrutinib. Out of those trials 29 have progressed to Phase 3 status. The majority of these investigations for this medication are based in Montvale, NJ however there is a global presence with 9051 sites running clinical studies into the benefits of iburtinib."

Answered by AI

How revolutionary is this medical research in comparison to prior studies?

"Ibrutinib research began in 2011, when Seagen Inc. conducted its initial trial involving 79 patients - thus granting the drug a Phase 2 approval. Nowadays, this medication is being studied across 47 countries and 1405 cities with 213 active studies taking place."

Answered by AI

Is the trial currently open to enrollees?

"According to clinicaltrials.gov, this trial is not presently enrolling patients - the first post was on June 20th 2016 and it underwent a revision in September 1st 2022. Despite that, 1937 other studies are accessible for potential participants at present."

Answered by AI
~4 spots leftby Mar 2025