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Bruton's Tyrosine Kinase Inhibitor

Ibrutinib for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Erlene Seymour, M.D.

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with relapsed or refractory classical HL who have previously received autologous stem cell transplant and/or allogeneic stem cell transplant

Patients must have received prior autologous stem cell transplant at least 12 weeks (3 months) before the first dose of ibrutinib and/or allogeneic stem cell transplant must have been completed at least 6 months prior to the first dose of Ibrutinib

Must not have

Nodular lymphocyte predominant Hodgkin's Lymphoma subtype

Major surgery within 4 weeks of first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of study entry until completion of testing up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how effective ibrutinib is in treating classical Hodgkin lymphoma that has come back or didn't respond to initial treatment. Ibrutinib may stop cancer cell growth by blocking enzymes needed for cell growth, or by affecting the tumor's environment or the immune system.

Who is the study for?

Adults with classical Hodgkin lymphoma that has come back or didn't respond to treatment, including those who've had stem cell transplants. Participants need good blood counts without transfusions for a week, no recent other cancer treatments, and must use effective birth control. Excluded are those with certain prior conditions like brain disease, recent heart issues, active infections or immune deficiencies.

What is being tested?

The trial is testing the effectiveness of a daily oral dose of Ibrutinib (560 mg) in patients with relapsed or refractory classical Hodgkin lymphoma. It explores how Ibrutinib might inhibit cancer growth by blocking enzymes needed for cell growth and modifying the tumor environment.

What are the potential side effects?

Ibrutinib may cause side effects such as bleeding problems, high blood pressure, irregular heartbeat, new cancers, infections due to low white blood cells count; diarrhea; muscle and bone pain; rash; nausea; bruising; tiredness and fever.

Eligibility Criteria

Inclusion Criteria

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

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I have classical Hodgkin lymphoma and have had a stem cell transplant.

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I had a stem cell transplant more than 3 months ago for autologous or more than 6 months ago for allogeneic before starting Ibrutinib.

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My Hodgkin lymphoma has not improved after 2 treatments and I can't have a stem cell transplant.

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I am not able to have children or I have a negative pregnancy test if I can.

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I am able to care for myself and perform daily activities.

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I have had at least 2 treatments for Hodgkin lymphoma, including brentuximab vedotin.

Exclusion Criteria

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

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My condition is a specific type of Hodgkin's Lymphoma.

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I have not had major surgery in the last 4 weeks.

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I understand the study's risks and can sign the consent form.

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I need treatment with a strong medication that affects liver enzymes.

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I finished treatment for an infection less than 14 days ago.

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I have no lasting side effects from previous cancer treatments.

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I have a bleeding disorder or hemophilia.

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I have a history of HIV, or I am currently infected with hepatitis B or C.

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I do not have any ongoing infections that aren’t being treated.

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I cannot swallow pills or have a condition that affects how my body absorbs nutrients.

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I am currently taking warfarin or similar blood thinners.

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I do not have any severe illnesses that could risk my safety or affect the study.

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I have a serious heart condition that is currently affecting me.

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I am willing and able to follow all study requirements.

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I have a serious liver condition.

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I have a known brain or spinal cord condition.

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I am currently experiencing GVHD or taking medication to prevent it.

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I had a stem cell transplant from a donor within the last 6 months.

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I have been treated with a BTK inhibitor before.

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I am not currently on any other cancer treatments or experimental drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study entry until completion of testing up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study entry until completion of testing up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study entry until completion of testing up to 24 months for reporting.