Inhibition of Anaphylaxis by Ibrutinib

Food Allergy Clinical Trial

Official title:

Inhibition of Anaphylaxis by Ibrutinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149315
• Other study ID #: 2016-357
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2017
• Est. completion date: November 14, 2018

Study information

• Verified date: November 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of food allergy to peanut (or tree nut).

• Male or female age = 18 years.

• Positive skin prick testing and basophil activation test to the trigger food, either peanut or tree nut.

• Adequate organ and marrow function as defined below:

• leukocytes = 3,000/mcL

• absolute neutrophil count = 1,500/mcL

• platelets = 100,000/mcl

• total bilirubin within normal institutional limits

• AST(SGOT)/ALT(SPGT) within normal institutional limits

• Creatinine within normal institutional limits

• Women of child bearing potential must agree to two forms of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.

• A female of child bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy; or

• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

• Ability to understand and the willingness to sign a written informed consent.

• Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, subjects must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking.

Exclusion Criteria:

• Subjects who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to study participation will be excluded, and those taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with SPT responses.

• Subjects with symptoms not consistent with type 1 food reactions (atopic dermatitis, eosinophilic esophagitis and any other non-IgE-mediated food sensitivities) will be excluded.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib.

• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, beta-blocker use or psychiatric illness/social situations that would limit compliance with study requirements.

• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

• Subjects on anticoagulants, anti-platelet therapy, or any other predisposition towards bleeding.

Related Conditions & MeSH terms

• Anaphylaxis
• Anaphylaxis Food
• Food Allergy
• Food Hypersensitivity

Intervention

Drug:
• Ibrutinib
Ibrutinib 420mg, PO once daily for 2-7 days

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	Feinberg School of Medicine, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of treatment for skin prick test	To determine the fewest ibrutinib doses required to eliminate food skin prick reactivity	30 days
Secondary	Length of treatment for basophil reactivity	To determine the fewest ibrutinib doses required to eliminate basophil reactivity to food antigen	30 days
Secondary	Skin compared to basophil reactivity	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.	30 days