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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
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
Secondary study objectives
Overall Response Rate (ORR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 4
~2060
Brentuximab Vedotin
2015
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,408 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,131 Total Patients Enrolled
Alex HerreraPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
77 Total Patients Enrolled