Study Phase 3

Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD) (iNTEGRATE)

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupProtein Kinase InhibitorsChemical SubgroupBruton's Tyrosine Kinase (BTK) InhibitorsCondition StudiedGraft Versus Host Disease
Sponsor Protocol NumberPCYC-1140-IMEnrollment193Data PartnerJohnson & Johnson% Female34.7%Mean/Median Age (Years)50.6% White54.4%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

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