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Inhibition of Anaphylaxis by Ibrutinib

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ClinicalTrials.gov Identifier: NCT03149315
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Anne Marie Singh, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Tracking Information
First Submitted Date  ICMJE May 5, 2017
First Posted Date  ICMJE May 11, 2017
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibition of Anaphylaxis by Ibrutinib
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Food Allergy
  • Anaphylaxis Food
Intervention  ICMJE Drug: Ibrutinib
Ibrutinib 420mg, PO once daily for 2-7 days
Other Name: Ibruvica
Study Arms  ICMJE 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.
Intervention: Drug: Ibrutinib
Publications * Dispenza MC, Pongracic JA, Singh AM, Bochner BS. Short-term ibrutinib therapy suppresses skin test responses and eliminates IgE-mediated basophil activation in adults with peanut or tree nut allergy. J Allergy Clin Immunol. 2018 May;141(5):1914-1916.e7. doi: 10.1016/j.jaci.2017.12.987. Epub 2018 Jan 31. Erratum in: J Allergy Clin Immunol. 2018 Oct;142(4):1374.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 14, 2018
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03149315
Other Study ID Numbers  ICMJE 2016-357
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anne Marie Singh, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators  ICMJE Feinberg School of Medicine, Northwestern University
Investigators  ICMJE
Principal Investigator: Anne Marie Singh, MD Ann & Robert H. Lurie Childrens Hospital
Principal Investigator: Bruce Bochner, MD Northwestern Feinberg School of Medicine
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP