A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)
Condition: Graft vs Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Ibrutinib
Intervention description: Participants will receive 420 mg (3 * 140 mg capsules) oral ibrutinib once daily starting on Week 1 Day 1, unless they have intervening unacceptable toxicity or meet other criteria for participants discontinuation.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with
      steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall
      cGVHD response (complete response [CR] and partial response [PR] defined by National
      Institutes of Health [NIH] consensus development project criteria [2014]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as
             modified National Institutes of Health (NIH) criteria (2014) below at any time
             post-hematopoietic cell transplant (post-HCT): a) Dependent disease, defined as, when
             glucocorticoid (prednisolone doses greater than or equal to [>=] 0.25 milligram per
             kilogram per day (mg/kg/day)or >=0.5 milligram per kilogram (mg/kg) every other day)
             are needed to prevent recurrence or progression of manifestations as demonstrated by
             unsuccessful attempts to taper the dose to lower levels on at least 2 occasions,
             separated by at least 8 weeks. In case of inability to taper the dose to less than or
             equal to (<=)0.25 mg/kg/day or <=0.5 mg/kg every other day (prednisolone doses) due to
             recurrence or progression of cGVHD manifestations, it is considered as
             steroid-dependent disease if the lowest tapering dose of the second occasion is equal
             or higher than the lowest tapering dose of the first occasion; b) Refractory disease,
             defined as, when cGVHD manifestations progress despite the use of a regimen containing
             glucocorticoid (prednisolone at >=1 mg/kg/day for at least 1 week) or persist without
             improvement despite continued treatment with glucocorticoid (prednisolone at >=0.5
             mg/kg/day or 1 mg/kg every other day) for at least 4 weeks

          -  Participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at
             study entry. The dose of steroids must be stable for 14 days prior to starting
             ibrutinib

          -  At the time of trial enrollment, participants may be receiving other immunosuppressive
             therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for
             14 days prior to starting ibrutinib

          -  Clinically stable or worsening cGVHD for a minimum of 14 days between screening and
             Day 1 cGVHD response assessment

          -  Karnofsky or Lansky (participants less than [<]16 years) performance status >=60

        Exclusion Criteria:

          -  Active acute graft versus host disease (GVHD)

          -  More than 3 previous systemic treatments for cGVHD. Treatment with glucocorticoids is
             considered a treatment for cGVHD and should be included in determining the number of
             previous treatments

          -  History of treatment with a tyrosine kinase inhibitor (example [e.g.] imatinib),
             purine analogs, or other cancer chemotherapy in the 4 weeks prior to starting
             ibrutinib. Participants may have received ibrutinib pre-transplant for other reasons
             besides cGVHD such as for the treatment of leukemia or lymphoma

          -  History of treatment with monoclonal T and B cell antibodies in the 8 weeks prior to
             starting ibrutinib

          -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of ibrutinib