Status:
COMPLETED
A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03474679
Start Date
May 1 2018
End Date
November 29 2021
Last Update
February 4 2025
Active Locations (15)
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1
Anjo Kosei Hospital
Anjo-shi, Japan, 446-8602
2
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, Japan, 113 8677
3
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan, 730-8619
4
Tokai University Hospital
Isehara, Japan, 259-1193