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



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - Any
Updated:2/17/2019
Start Date:December 2016
End Date:March 2020
Contact:PCYC1140 Study Team
Email:1140@pcyc.com

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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.


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)
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Chapel Hill, North Carolina 27599
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5801 South Ellis Avenue
Chicago, Illinois 60637
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4100 John R
Detroit, Michigan 48201
800-527-6266
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425 University Blvd.
Indianapolis, Indiana 46202
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740 South Limestone Street
Lexington, Kentucky 40536
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Miami, Florida 33124
(305) 284-2211
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
Nashville, Tennessee 37232
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116th St and Broadway
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60 Crittenden Blvd # 70
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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1365 Clifton Rd NE
Atlanta, Georgia 30322
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13123 East 16th Avenue
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22 South Greene Street
Baltimore, Maryland 21201
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450 Brookline Ave
Boston, Massachusetts 2215
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Bronx, New York 10461
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171 Ashley Avenue
Charleston, South Carolina 29425
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1200 West Loyola Avenue
Chicago, Illinois 60626
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Darlinghurst, 2010
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500 S Preston St
Louisville, Kentucky
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529 S Jackson St
Louisville, Kentucky 40202
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Morgantown, West Virginia 26506
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195 Little Albany Street
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101 Nicolls Road
New York, New York 10595
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Pittsburgh, Pennsylvania 15232
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Rochester, Minnesota 55905
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10460 North 92nd Street
Scottsdale, Arizona 85258
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450 Serra Mall
Stanford, California 94305
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Stony Brook, New York 11794
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111 Michigan Ave NW
Washington, District of Columbia
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