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 |
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.
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)
We found this trial at
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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4100 John R
Detroit, Michigan 48201
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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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Miami A private research university with more than 15,000 students from around the...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 800-811-8480
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Mary Flowers
Phone: 206-667-6819
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
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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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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171 Ashley Avenue
Charleston, South Carolina 29425
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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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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University of Louisville The University of Louisville is a state supported research university located in...
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James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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195 Little Albany Street
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Phone: 732-235-5972
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Pittsburgh, Pennsylvania 15232
Phone: 412-623-5613
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10460 North 92nd Street
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Phone: 480-323-7335
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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111 Michigan Ave NW
Washington, District of Columbia
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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