Inhibition of Anaphylaxis by Ibrutinib (NCT03149315) | Clinical Trial Compass
CompletedPhase 2
Inhibition of Anaphylaxis by Ibrutinib
United States6 participantsStarted 2017-04-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 Engl…
What they're measuring
1
Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods
Timeframe: 7 days
Trial details
NCT IDNCT03149315
SponsorAnn & Robert H Lurie Children's Hospital of Chicago