Clinical Trial: Inhibition of Anaphylaxis by Ibrutinib

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Inhibition of Anaphylaxis by Ibrutinib

Brief Summary: This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to adults with food allergy to inhibit food allergy responses.

Detailed Summary: This is open-label study designed to determine the fewest doses and shortest length of time, from two days to up to 7 days, needed for ibrutinib to fully inhibit tests for food allergy, and to determine the length of persistence of efficacy after the drug is stopped.
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome: Length of treatment for skin prick test [ Time Frame: 30 days ]

To determine the fewest ibrutinib doses required to eliminate food skin prick reactivity


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of treatment for basophil reactivity [ Time Frame: 30 days ]
    To determine the fewest ibrutinib doses required to eliminate basophil reactivity to food antigen
  • Skin compared to basophil reactivity [ Time Frame: 30 days ]
    To determine the timing of when skin prick testing (SPT) response to peanut or tree nuts is altered compared to basophil activation test (BAT) responses.


Original Secondary Outcome: Same as current

Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: May 5, 2017
Date Started: April 10, 2017
Date Completion: September 1, 2017
Last Updated: May 9, 2017
Last Verified: May 2017