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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Ibrutinib 420mg, PO once daily for 2-7 days
Ann & Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods
The primary outcome was the number of ibrutinib doses (2, 4, or 7 doses) required to maximally suppress food skin prick reactivity to foods. All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Skin testing to peant and tree nuts was done at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).
Time frame: 7 days
Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity
The primary outcome was to determine the fewest ibrutinib doses (2, 4, or 7 doses) required to suppress basophil reactivity (BAT). All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Basophil activation testing was perfmored at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).
Time frame: 7 days
Time to Recovery of Skin Test Reactivity
Another secondary outcome was to determine the timing of when skin prick testing (SPT) response to peanut or tree nuts returned to baseline compared to basophil activation test (BAT) responses. Participants underwent SPT and BAT weekly after cessation of ibrutinib therapy. SPT and BAT that were ≥80% of baseline values were considered to have "returned to baseline."
Time frame: 30 days
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