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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Miami, Florida 33124
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201 Dowman Dr
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Chapel Hill, North Carolina 27599
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-8030
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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425 University Blvd.
Indianapolis, Indiana 46202
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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740 South Limestone Street
Lexington, Kentucky 40536
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Minneapolis, Minnesota 55455
(612) 625-5000
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Mary Flowers
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Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
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Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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13123 East 16th Avenue
Aurora, Colorado 80045
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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450 Brookline Ave
Boston, Massachusetts 2215
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Bronx, New York 10461
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1200 West Loyola Avenue
Chicago, Illinois 60626
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Darlinghurst, 2010
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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Morgantown, West Virginia 26506
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Phone: 304-598-4511
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195 Little Albany Street
New Brunswick, New Jersey 08903
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101 Nicolls Road
New York, New York 10595
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New York, New York 10065
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Orlando, Florida 32804
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Palo Alto, California 94304
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Pittsburgh, Pennsylvania 15232
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Rochester, Minnesota 55905
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San Francisco, California 94143
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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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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stony Brook, New York 11794
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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