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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

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

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