iNTEGRATE Study

Disease: Chronic Graft Versus Host Disease
Protocol: PCYC-1140-IM

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD) (iNTEGRATE)

Study Schema (N=186 subjects)

Stratified by:
  • Age group (12-17 years old vs. ≥18 years old)
  • NIH Global Severity grade (moderate vs. severe)
  • Ongoing use of systemic immunosuppressants that were initiated for either treatment of or prophylaxis for acute GVHD
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Primary Objective

  • To evaluate the efficacy of ibrutinib in combination with prednisone (Arm A) versus placebo in combination with prednisone (Arm B) based on the response rate at 24 weeks as determined by NIH Consensus Development Project criteria in subjects with new onset moderate to severe cGVHD

Key Eligibility Criteria

(Not a complete list of inclusion and exclusion criteria)

Inclusion Criteria:
  • New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development Project Criteria
  • Need for systemic treatment with corticosteroids for cGVHD
  • No previous systemic treatment for cGVHD (including extracorporeal photopheresis [ECP])
  • May be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but the doses of these medications must have been stable for at least 2 weeks prior to Screening
  • Age ≥12 years old
  • Karnofsky or Lansky (subjects <16 years) performance status ≥60

Exclusion Criteria      
  • Received any previous systemic treatment for cGVHD (with the exception of systemic corticosteroids started for cGHVD within 7 days of randomization)
  • Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD
  • Any uncontrolled active systemic infection or active infection requiring systemic treatment
  • Progressive underlying malignant disease or any post-transplant lymphoproliferative disease
  • Known bleeding disorders
  • Active hepatitis C virus (HCV) or hepatitis B virus (HBV) 


For more information, please visit https://www.clinicaltrials.gov/ct2/show/NCT02959944

 

For more information on this trial, click below

The information provided herein may contain references to ibrutinib or a use of ibrutinib which has not been approved by any regulatory agency. Providing this information should not be construed as recommending the use of ibrutinib for uses which may not have been approved by any regulatory agency. The safety and efficacy of the investigational use of ibrutinib has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. For additional information, you may visit www.clinicaltrials.gov. For products approved by any regulatory agency please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product for its approved indications.