Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Subjects With New Onset cGVHD

  • Interventional
  • Not Recruiting
  • NCT02959944
Eligibility Details Visit Clinicaltrials.gov

Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) (INTEGRATE)

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Gender
All

Age Group
12 Years and up

Accepting Healthy Volunteers?
No

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])

         - Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d

         - 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 corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form.

         - Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD

         - Any uncontrolled infection or active infection requiring ongoing 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)
  • Graft Versus Host Disease (GVHD)

At a Glance

National Government IDNCT02959944

IRB#IRB17-0108

Lead SponsorPharmacyclics LLC.

Lead PhysicianSatyajit Kosuri

Collaborator(s)N/A

EligibilityAll
12 Years and up
Not Recruiting