Ibrutinib for Chronic Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySteven Z Pavletic, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing ibrutinib, a pill that blocks a protein causing harmful immune reactions, in adults with newly diagnosed moderate or severe chronic graft-versus-host disease (cGVHD). The goal is to see if this drug can help control the disease by reducing the immune system's attack on the body. Ibrutinib was the first agent approved by the U.S. Food and Drug Administration for the treatment of chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

Eligibility Criteria

Adults over 18 with newly diagnosed moderate or severe chronic Graft-versus-Host Disease after a stem cell or bone marrow transplant can join. They must be responding to current treatments, agree to use birth control, and have no uncontrolled infections, bleeding disorders, other cancers (with some exceptions), heart issues, hepatitis B/C, or known allergy to Ibrutinib.

Inclusion Criteria

I have had a stem cell transplant from a donor.

I have been newly diagnosed with moderate or severe chronic GvHD and need systemic immunosuppression.

Your test results must be within certain ranges.

+6 more

Exclusion Criteria

I do not have any uncontrolled infections or bleeding disorders.

My cancer has returned or worsened.

The researchers can decide not to include you for other reasons and they will write it down in your medical record.

+8 more

Participant Groups

The trial is testing if Ibrutinib can help as a first-line treatment for cGVHD without needing steroids. Participants will take the drug daily for up to two years and attend regular check-ups including physical exams and lung function tests while keeping a medicine diary.

1Treatment groups

Experimental Treatment

Group I: Ibrutinib Without CorticosteroidsExperimental Treatment16 Interventions

Determine response rate via continuous daily dose by mouth to determine efficacy

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

🇪🇺 Approved in European Union as Imbruvica for: