Inhibition of Anaphylaxis by Ibrutinib

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT03149315
Phase
PHASE2
Status
Completed

Conditions

  • Anaphylaxis Food
  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 420mg, PO once daily for 2-7 days

Study Details

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.

Key Dates

Start date
Apr 10, 2017
Status verified
Jan 2025
Primary completion
Nov 14, 2018
Completion
Nov 14, 2018

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Administration
    Allergic subjects will be given ibrutinib 420mg daily for 2-7 doses to determine the shortest amount of time and fewest ibrutinib doses required to suppress food skin prick testing and basophil activation test reactivity.

Primary Outcome Measure

Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods [ Time Frame: 7 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Childrens Hospital of ChicagoChicagoIllinois60611-

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