Summary

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

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 DiseasePCYC1140PCYC1140IM1140IbrutinibGVHDSteroid dependentrefractorychronicPCI32765IMBRUVICAPharmacyclicsPCYCgraft versus host diseaseimmunologynew onset graft versus host diseaseINTEGRATECorticosteroidsprednisoneGraft 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])
  • 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

You CAN'T join if...

  • 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)

Locations

  • University Of California - San Franciscoaccepting new patients
    San FranciscoCalifornia94143United States
  • Stanford Universityaccepting new patients
    StanfordCalifornia94305United States

Lead Scientist

  • Aaron Logan
    The phone number listed above is my direct office number. If you prefer to contact the outpatient clinic, please call 415-353-2421. The clinic fax number is 415-353-2467.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02959944
Phase
Phase 3
Study Type
Interventional
Last Updated