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Summary

for people ages 12 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Keywords

Chronic Graft Versus Host Disease PCYC1140 PCYC1140IM 1140 Ibrutinib GVHD Steroid dependent refractory chronic PCI32765 IMBRUVICA Pharmacyclics PCYC graft versus host disease immunology new onset graft versus host disease INTEGRATE Corticosteroids prednisone Graft vs Host Disease

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • Received any previous systemic treatment for cGVHD
  • 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)

Locations

  • University Of California - San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • Lucile Packard Children's Hospital Stanford accepting new patients
    Palo Alto, California, 94304, United States
  • Stanford University accepting new patients
    Stanford, California, 94305, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02959944
Phase
Phase 3
Lead Scientist
Aaron Logan
Study Type
Interventional
Last Updated
November 15, 2017
I’m interested in this study!