Ibrutinib for Hodgkin's Lymphoma

Palo Alto (17 mi)

Overseen byErlene Seymour, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Barbara Ann Karmanos Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, by altering the environment around the tumor or by affecting the immune system.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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

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

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

Exclusion Criteria

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

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

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

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

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

I have no lasting side effects from previous cancer treatments.

I have a bleeding disorder or hemophilia.

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

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

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

I am currently taking warfarin or similar blood thinners.

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

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

I am willing and able to follow all study requirements.

I have a serious liver condition.

I have a known brain or spinal cord condition.

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

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

I have been treated with a BTK inhibitor before.

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

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib)Experimental Treatment3 Interventions

Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: